Sofsilk 170001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884521126845), received between Aug 31, 2017 and Jun 15, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 17137866 ↗
• MalfunctionAug 31, 2017Detachment Of Device Component; Detachment Of Device Component

  DURING A LAPAROSCOPIC NISSEN PROCEDURE ON FUNDOPLICATION, THE DEVICE WAS DIFFICULT TO TOGGLE, LOAD AND UNLOAD, THE DEVICE COULD NOT PASS THE NEEDLE AND IT WAS DROPPED. THE NEEDLE FELL INTO THE PATIENT¿S CAVITY AND THE NEEDLE WAS RETRIEVED. THEY OPENED A NEW DEVICE AND RELOAD TO COMPLETE THE CASE AND RESOLVED THE ISSUE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6833623 ↗

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