Polysorb 170051Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20884521126753), received between Sep 28, 2017 and Mar 13, 2024 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TRANSABDOMINAL PRE-PERITONEAL (TAPP) HERNIOPLASTY, THE NEEDLE BROKE WITHIN THE SURGICAL FIELD DURING THE INTERVENTION. THE NEEDLE WAS REMOVED WITH A HOLDER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18893763 ↗
• InjuryOct 7, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, IN CLOSURE OF VAGINAL CUFF, A PORTION OF THE NEEDLE FELL INTO PATIENT'S CAVITY. THE PIECE WAS NOT RETRIEVED AS THE SURGEON WAS UNABLE TO LOCATE. TO RESOLVE THE ISSUE AND COMPLETE THE CASE, A NEW RELOAD WAS USED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 15565940 ↗
• MalfunctionFeb 3, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ROUX-EN-Y BYPASS, WHEN COMPLETING THE GASTROJEJUNAL ANASTOMOSIS, TRAUMA TO THE TISSUE WAS NOTED DUE TO THE NEEDLE NOT PASSING THROUGH THE JAWS SMOOTHLY. UPON CLOSER INSPECTION, WHEN THE NEEDLE WAS IN THE LEFT JAW OF THE DEVICE, THE NEEDLE APPEARED TO BE LOOSE. NEW HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11272979 ↗
• InjuryOct 2, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRECTOMY, A NEEDLE FRAGMENT PARTIALLY BROKE OFF WHILE THE SURGEON WAS SUTURING THE STOMACH WALL. THE REMAINING TIP OF APPROX. 2MM WAS LEFT ON THE DEVICE. THE REMAINING FRAGMENT WAS UNABLE TO BE FOUND. THE SURGEON PROCEEDED WITH THE CASE THEREAFTER.

  Patient problems: Foreign Body In Patient

  MAUDE report 10618624 ↗
• MalfunctionDec 20, 2019Entrapment of Device; Human-Device Interface Problem; Entrapment of Device; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, THE SURGEON EXPERIENCED RESISTANCE WHEN GOING THROUGH THE TISSUE AS THE SURGEON TOGGLED THE NEEDLE BETWEEN THE JAWS. THE NEEDLE WOULD GET STUCK AS IF THERE WAS A BARB ON THE NEEDLE SHAFT THAT WAS CATCHING ON THE TISSUE. DOCTOR MENTIONED THAT 3 OF 4 INSTRUMENTS FELT GRITTY UPON NEEDLE EXCHANGE BETWEEN THE JAWS WHEN TOGGLING. TISSUE THICKNESS APPEARED NORMAL. THE FOURTH AND FINAL LOAD FELT SMOOTH AND WENT THROUGH WITH OUT RESISTANCE AND THE SURGEON CONTINUED TO USE THE HANDLE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9504977 ↗
• MalfunctionDec 20, 2019Entrapment of Device; Human-Device Interface Problem; Entrapment of Device; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, THE SURGEON EXPERIENCED RESISTANCE WHEN GOING THROUGH THE TISSUE AS THE SURGEON TOGGLED THE NEEDLE BETWEEN THE JAWS. THE NEEDLE WOULD GET STUCK AS IF THERE WAS A BARB ON THE NEEDLE SHAFT THAT WAS CAUGHT ON THE TISSUE. DOCTOR MENTIONED THAT 3 OF 4 INSTRUMENTS FELT GRITTY UPON NEEDLE EXCHANGE BETWEEN THE JAWS WHEN TOGGLING. TISSUE THICKNESS APPEARED NORMAL. THE FOURTH AND FINAL LOAD FELT SMOOTH AND WENT THROUGH WITH OUT RESISTANCE AND THE SURGEON CONTINUED TO USE THE HANDLE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9503705 ↗
• MalfunctionJul 25, 2018Detachment of Device or Device Component; Device Dislodged or Dislocated; Human-Device Interface Problem; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS BEING APPLIED TO THE JEJUNUM DURING THE SEWING OF THE GASTROJEJUNOSTOMY ON A LAPAROSCOPIC ROUX EN Y GASTRIC BYPASS, THE DEVICE WAS DIFFICULT TO UNLOAD AT ONE POINT. THE NEEDLE DISENGAGED COMPLETELY FROM THE DEVICE BUT WAS STILL IN THE SMALL BOWEL WITH THE STRAND OF SUTURE ATTACHED, SO IT WAS VISIBLE THE ENTIRE TIME. A NEW RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7719179 ↗
• MalfunctionJul 23, 2018Detachment of Device or Device Component; Device Dislodged or Dislocated; Human-Device Interface Problem; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS BEING APPLIED TO THE JEJUNUM DURING THE SEWING OF THE GASTROJEJUNOSTOMY ON A LAPAROSCOPIC ROUX EN Y GASTRIC BYPASS, THE DEVICE WAS DIFFICULT TO UNLOAD AT ONE POINT. THE NEEDLE DISENGAGED COMPLETELY FROM THE DEVICE BUT WAS STILL IN THE SMALL BOWEL WITH THE STRAND OF SUTURE ATTACHED, SO IT WAS VISIBLE THE ENTIRE TIME. A NEW RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7712521 ↗
• MalfunctionJul 10, 2018Difficult to Remove; Detachment of Device or Device Component; Device Dislodged or Dislocated; Human-Device Interface Problem; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS BEING APPLIED TO THE JEJUNUM DURING THE SEWING OF THE GASTROJEJUNOSTOMY ON A LAPAROSCOPIC ROUX EN Y GASTRIC BYPASS, THE DEVICE WAS DIFFICULT TO UNLOAD AT ONE POINT. THE NEEDLE DISENGAGED COMPLETELY FROM THE DEVICE BUT WAS STILL IN THE SMALL BOWEL WITH THE STRAND OF SUTURE ATTACHED, SO IT WAS VISIBLE THE ENTIRE TIME. A NEW RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7674237 ↗
• MalfunctionSep 28, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, THE NEEDLE FELL OUT OF THE JAWS AND WAS RETRIEVED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6901613 ↗

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