Sofsilk 170002Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20884521126852), received between Jun 25, 2018 and Jul 10, 2025 — classified as 3 injuries, 6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Difficult to Open or Close; Human-Device Interface Problem; Difficult to Open or Close; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ONE ANASTOMOSIS GASTRIC BYPASS PROCEDURE, A SMALL HIATAL HERNIA WAS IDENTIFIED AND THE DEVICE WAS USED TO CLOSE THE SPACE BETWEEN THE PILLARS AND THE SURGEON HAD TO USE BOTH HANDS TO CLOSE THE DEVICE. THE DEVICE WAS DIFFICULT TO TOGGLE AND UNLOAD AND AFTER REMOVAL FROM THE PATIENT CAVITY, THE JAWS COULD NOT BE OPENED AND THE NURSE COULD NOT RETRIEVE THE RELOAD. ANOTHER DEVICE WAS OPENED AND RELOADED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470244 ↗
• InjuryFeb 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A GASTROPEXY PROCEDURE INVOLVING THE SUTURE LOADING UNIT, A PIECE OF THE NEEDLE BROKE OFF AND REMAINED IN THE PATIENT'S DIAPHRAGM. THE SURGEON WAS UNABLE TO LOCATE THE BROKEN NEEDLE PIECE. THE INCIDENT OCCURRED IN A HOSPITAL SETTING. THE SURGEON DECIDED TO LEAVE THE BROKEN PIECE IN PLACE, AS IT WAS SMALL AND LOCATED LATERALLY AWAY FROM THE HEART, TO AVOID FURTHER RISK BY SEARCHING FOR IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21394597 ↗
• MalfunctionSep 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION OF STOMACH, THE NEEDLE WAS POPPING OUT WHEN CLOSING THINGS UNDER TENSION. IT WORKED FINE UNDER REGULAR TENSION. ANOTHER RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17730512 ↗
• MalfunctionJun 15, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC HIATAL HERNIA REPAIR, WHILE REPAIRING THE HERNIA, BOTH RELOADS HAD A SUTURE BREAKAGE. THE SURGEON HAD TO OPENED MORE RELOADS TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17138160 ↗
• MalfunctionApr 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHEN THE DEVICE WAS APPLIED ON TISSUE, AS THE SUTURING DEVICE TIPS DID NOT FIT PROPERLY, THE RIGHT AND LEFT SIDES WERE WIDENED AND THE NEEDLE FELL INTO THE PATIENT'S ABDOMEN. THE NEEDLE WAS REMOVED FROM THE PATIENT WITHOUT ANY PROBLEMS. A NEW NEEDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16747384 ↗
• MalfunctionSep 6, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HELLER MYOTOMY PROCEDURE, WHEN SURGEON WAS STITCHING DURING WRAP OF UPPER PART OF THE STOMACH AROUND THE LOWER ESOPHAGEAL SPHINCTER TO STRENGTHEN IT, THE NEEDLE BROKE BUT WAS RETRIEVED SUCCESSFULLY TO SATISFACTION OF THE SURGEON WITH OUT PERFORMING AN X-RAY. A SECOND DEVICE WAS USED AND THE JAWS WOULD NOT OPEN AND IT WAS DIFFICULT TO TOGGLE. ALSO THE DEVICE WAS DIFFICULT TO LOAD AND UNLOAD AS THE RELOAD WAS STUCK IN JAWS. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366726 ↗
• InjuryAug 12, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GENERAL SURGERY, MOBILE IMAGING WAS NEEDED TO LOCATE BROKEN NEEDLE FROM INSTRUMENT THAT FELL INTO CAVITY OF THE PATIENT AND WAS RETRIEVED. SURGICAL TIME WAS EXTENDED MORE 30 MINUTES DUE TO THE PRODUCT PROBLEM.

  Patient problems: No Code Available; Radiation Exposure, Unintended; Unintended Radiation Exposure

  MAUDE report 10399673 ↗
• MalfunctionJun 27, 2018Difficult or Delayed Positioning; Human-Device Interface Problem; Difficult or Delayed Positioning; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, THE NEEDLE WAS DIFFICULT TO TOGGLE AND WOULD NOT SLIDE THROUGH THE TISSUE. SO THEY PHYSICALLY HAD TO SLIDE THE TISSUE OFF OF THE NEEDLE WHICH CAUSED A LARGER THAN NORMAL HOLE IN THE TISSUE FROM THE NEEDLE. 4 DEVICES WERE CAUSING ISSUES DURING THE CASE. THEY KEPT TRYING TO GET A NEW DEVICE AND THE NEW ONES WERE STILL CAUSING ISSUES. THERE WAS STICKING WHEN TOGGLING THE DEVICE, LOADING AND UNLOADING, THE DEVICE WOULD ALSO CLICK LOUDLY ON SOME WHEN BEING TOGGLED AND THE NEEDLE WAS LOOSE ON SOME AS WELL. MORE DEVICES WERE OPENED TO COMPLETE THE CASE. THE TISSUE WAS STRETCHED DUE TO STRUGGLING TO GET THE NEEDLE OUT OF THE TISSUE SO THE HOLE WAS LARGER THAN NORMAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient; Tissue Damage

  MAUDE report 7641343 ↗
• InjuryJun 25, 2018Material Frayed; Material Frayed

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE FIRST DEVICE WOULD NOT TOGGLE PROPERLY ON THE VERY FIRST RELOAD. IT WAS DIFFICULT TO LOAD AND UNLOAD AS THE SEEMED TO HAVE BEEN MISALIGNED. THEY WORKED ON THE TOGGLES TO "LOOSEN" IT UP AND WERE ABLE TO FINISH THE STITCH BUT REQUESTED A NEW HANDLE. THE SUTURE WAS ALSO FRAYING CLOSE TO THE NEEDLE. THE SECOND DEVICE HAD DIFFICULTY TOGGLING THROUGH THICK TISSUE. THE SURGEON SAID SHE HAD TO WORK INTO THE TISSUE TO GET IT TO TOGGLE. THE NEEDLE WOULD NOT TRANSFER EASILY IT LEFT A SLIGHT LARGER HOLE IN THE TISSUE BECAUSE THE TISSUE NEEDED TO BE REMOVED FROM THE DEVICE WITH A GRASPER. IT WAS OVER SEWN.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 7634985 ↗

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