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Viscera Retainer

The Glassman Viscera Retainer, commonly called the FISH, is a sterile, single-use flexible synthetic-polymer paddle temporarily placed over abdominal viscera while an internal wound layer is sutured. It is not a metal alternative to a separate FISH device: Glassman and FISH refer to the same current product family.[1][2]

Current Device Identity​

Current FDA device records list pediatric, small, medium, large, extra-large and jumbo models in commercial distribution. The active device definition is a thin flexible synthetic-polymer paddle that may have an external removal aid; the device is supplied sterile and is single use.[1]

The manufacturer describes a pliable paddle with an integral ring used to signal and facilitate removal. Check the selected model’s label and instructions for exact size and handling. The manufacturer lists radiopaque inner strips in models 3202, 3204, 3206, 3207 and 3212; models 3200, 3201 and 3203 have no inner strip and are not radiopaque.[2]

Do not apply the FISH label to a metal malleable retractor. A malleable retractor is a separate reusable instrument that can also provide a temporary barrier during closure.

Practical Role in Abdominal Closure​

The retainer is placed between the viscera and the abdominal-wall layer being closed. It can help keep bowel away from the needle and suture path while fascial bites are placed. Relevant settings include:

  • open urinary diversion, cystectomy and augmentation cystoplasty, where mobilized or distended bowel crowds the closure plane;
  • open sacrocolpopexy and large prolapse repairs closed through an extended Pfannenstiel or low midline incision;
  • reoperative abdomens with adhesions, prior radiation, prior mesh or prior diversion;
  • obese patients with a deep wound, where the needle tip is hardest to see;
  • pediatric augmentation, Mitrofanoff and exstrophy closure, where the abdominal wall is thin and the working space small.

Safe-Use Principles​

  1. Confirm the product, size, package integrity and label instructions before use.
  2. Place the paddle so the suture path is separated from the underlying viscera without trapping bowel against the wound edge.
  3. Keep the removal ring or other removal aid visible and include the device in the operative count.
  4. Withdraw the device before completing external wound closure, then visually confirm removal and inspect the protected field as exposure permits.
  5. Do not reuse a single-use FISH or substitute undocumented reprocessing instructions.

The device must come out before the last sutures are placed, so the final fascial bites are made without a shield.[6] Common practice is to withdraw it in steps as bites are tied, keep the bowel edge in view with a handheld retractor for the last one or two bites, and have an assistant hold the bowel back. This is a technique commonly taught rather than a tested protocol.

The need for removal is clinically important. A single FDA adverse-event report documents a retained model 3204 detected radiographically after surgery and removed at reoperation; that report demonstrates a possible failure mode but cannot estimate its incidence.[3]

Evidence Boundaries​

No reviewed clinical comparison establishes FISH-versus-no-FISH outcome effects. Published enterotomy studies instead describe the background risk during ventral-hernia repair or adhesiolysis:

  • In an Americas Hernia Society Quality Collaborative cohort of 5,916 ventral-hernia repairs, recognized inadvertent enterotomy occurred in 1.9% and was associated with increased surgical-site infection, reoperation, readmission and mortality.[4]
  • In a prospective cohort of 133 abdominal-wall repairs, 17 patients (12.8%) sustained enterotomy during adhesiolysis; adhesiolysis duration was the independent predictor.[5]

Retrospective and review data put the risk higher in reoperative abdomens. Inadvertent enterotomy occurred in 52 of 270 reoperations (19%) in a single-center retrospective review, most often when dividing lower abdominal and pelvic adhesions, and a review cites rates as high as 20% in open surgery.[7][8]

None of these studies tested a viscera retainer or isolated needle injury during final closure, so none of the rates should be presented as device efficacy.

The 2023 WSES emergency-laparotomy guideline cites one 200-patient randomized trial in elective and emergency general surgery comparing blunt-tapered with sharp needles for fascial closure; glove perforation was the primary endpoint and omentum or bowel puncture was secondary. Its formal statement makes no recommendation on needle type, while the discussion recommends blunt-tapered needles to decrease glove and visceral perforation.[9]

Investigational Biodegradable Barrier​

Kaymakcalan and colleagues described a puncture-resistant degradable CC-DHA elastomer intended to remain in situ during closure. Testing included mechanical work and a murine laparotomy model showing dissolution without observed toxicity or intra-abdominal scarring.[6] This is preclinical biomaterial evidence, not a clinically validated or routinely available replacement for a current viscera retainer.

  • Malleable (Ribbon) Retractor. A separate reusable instrument sometimes used as a temporary barrier.
  • Laparotomy Pads. Packing and protection adjuncts that require strict counting.
  • Bookwalter and Balfour. Exposure systems used during the main operation rather than substitutes for a labeled visceral-retention paddle.

References​

1. US National Library of Medicine. "Viscera Retainer, Fish (00613244000035)." AccessGUDID. Public version February 24, 2023. Device record

2. Adept-Med International. "Glassman Viscera Retainer, FISH — frequently asked questions." Manufacturer information

3. US Food and Drug Administration. "MAUDE Adverse Event Report: Glassman Viscera Retainer; Viscera Retainer, FISH, model 3204." Report 2918699-2017-70001. January 10, 2017. FDA report

4. Krpata DM, Prabhu AS, Tastaldi L, et al. "Impact of inadvertent enterotomy on short-term outcomes after ventral hernia repair: an AHSQC analysis." Surgery. 2018;164(2):327–332. doi:10.1016/j.surg.2018.04.003

5. ten Broek RP, Schreinemacher MH, Jilesen AP, et al. "Enterotomy risk in abdominal wall repair: a prospective study." Ann Surg. 2012;256(2):280–287. doi:10.1097/SLA.0b013e31826029a8

6. Kaymakcalan OE, Jin JL, Sun Z, et al. "Transient phase behavior of an elastomeric biomaterial applied to abdominal laparotomy closure." Acta Biomater. 2017;58:413–420. doi:10.1016/j.actbio.2017.05.055

7. Van Der Krabben AA, Dijkstra FR, Nieuwenhuijzen M, et al. "Morbidity and mortality of inadvertent enterotomy during adhesiotomy." Br J Surg. 2000;87(4):467–471. doi:10.1046/j.1365-2168.2000.01394.x

8. van Goor H. "Consequences and complications of peritoneal adhesions." Colorectal Dis. 2007;9(Suppl 2):25–34. doi:10.1111/j.1463-1318.2007.01358.x

9. Frassini S, Cobianchi L, Fugazzola P, et al. "ECLAPTE: Effective closure of laparotomy in emergency—2023 World Society of Emergency Surgery guidelines for the closure of laparotomy in emergency settings." World J Emerg Surg. 2023;18:42. doi:10.1186/s13017-023-00511-w