Polysorb 170057Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20884521126593), received between Aug 9, 2017 and May 15, 2024 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K934738); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TRANS ANAL ENDOSCOPIC RESECTION OF POLYPECTOMY SITE, THE SURGEON WAS USING THE DEVICE WITH 2-0 POLYSORB NEEDLE. THE DEVICE INSIDE PATIENT AND NEEDLE BROKE IN HALF. HALF OF NEEDLE REMAINED IN THE DEVICE AND UNABLE TO LOCATE THE REMAINING HALF OF THE NEEDLE. X-RAYS POST PROCEDURE WITH NO OBVIOUS TARGET.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 19324511 ↗
• InjurySep 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS, DURING INTERNAL CLOSURE OF TROCAR SITE IN THE ABDOMINAL WALL, THE NEEDLE FROM THE RELOAD DETACHED FROM THE JAWS AND REMAINED IMPLANTED IN THE PATIENT¿S ABDOMINAL WALL. THE NEEDLE COULD NOT BE FOUND OR RETRIEVE. THE SURGEON OPENED A TRANSFACIAL (ENDOCLOSE) SUTURE PASSER TO CLOSE THE PORT SITE. THE PATIENT IS CURRENTLY FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17730206 ↗
• InjuryMar 9, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROUX-EN-Y BYPASS PROCEDURE, WHEN CLOSING THE FACIAL TROCAR SITE FROM THE LAPAROSCOPIC APPROACH THROUGH THE ABDOMEN, AN ESTIMATED 2 MM PIECE OF NEEDLE BROKE OFF IN THE PATIENT'S FASCIA AND MUSCLE ABDOMINAL AREA. THE BROKEN NEEDLE WAS NOT ABLE TO BE RETRIEVED. THE SURGEON OPENED ANOTHER RELOAD TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16516405 ↗
• MalfunctionApr 10, 2022Break; Detachment of Device or Device Component; Human-Device Interface Problem; Break; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER DURING THE GASTRIC BYPASS VIA LAPAROSCOPIC PROCEDURE WHILE CREATING ANASTOMOSIS, WHILE PASSING THE NEEDLE THROUGH TISSUE IT WAS STICKING. THE NEEDLE BROKE IN HALF INTO THE STOMACH TISSUE AND IT WAS RETRIEVED WITH A GRASPER. TO RESOLVE THE ISSUE, THE SURGEON OPENED SEVERAL LOTS OF THE INSTRUMENT AND EACH DEVICE HAD STICKING ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14069422 ↗
• MalfunctionJul 12, 2018Failure to Align; Human-Device Interface Problem; Mechanical Jam; Mechanics Altered; Failure to Align; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHEN UNLOADING THE DEVICE, ONE SIDE OF THE RABBIT EARS JAMMED AND THE OTHER SIDE LIFTED. ANOTHER INSTRUMENT WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7682830 ↗
• MalfunctionDec 12, 2017Break; Detachment Of Device Component; Human-Device Interface Problem; Break; Detachment Of Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC BYPASS, THE DEVICE WAS DIFFICULT TO TOGGLE WHILE BEING APPLIED ON STOMACH. SURGEON SAID THE DEVICE SEEMED "STICKY" WHEN TOGGLING BACK AND FORTH. WHEN APPLYING THE DEVICE TO THE STOMACH TISSUE, THE NEEDLE BROKE IN HALF WHEN THEY CLOSED DOWN ON THE DEVICE TO TOGGLE. THEY WERE ABLE TO SEE THE PIECE OF THE NEEDLE AND IMMEDIATELY RETRIEVED IT. NEW DEVICE WAS USED IN ORDER TO COMPLETE THE CASE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7109329 ↗
• MalfunctionAug 10, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY IN A ROUX-EN-Y GASTROJEJUNOSTOMY/ GASTRIC BYPASS, THE DEVICE NEEDLE BROKE OFF AND FELL INTO THE PATIENTS CAVITY, IT WAS RETRIEVED USING A LAPAROSCOPIC GRASPER. A NEW ENDOSTITCH NEEDLE WAS OPENED AND LOADED ON THE SAME DEVICE TO RESOLVED THE ISSUE AND COMPLETE THE CASE. THE PATIENT WAS ALIVE WITH NO INJURY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6787108 ↗
• MalfunctionAug 9, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, THE NEEDLE WAS LOOSE WHILE USING THE DEVICE. A NEW DEVICE WAS USED IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6776925 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K934738. One submission often covers many models, so check the product and lot details in each record.

• Z-2281-2026 · Apr 15, 2026 · Open, Classified
  Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
• Z-2543-2017 · May 3, 2017 · Terminated
  Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU