Sofsilk 170004Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 20884521126906), received between Oct 2, 2017 and Aug 11, 2026 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50213844 ↗
• MalfunctionSep 9, 2025Component or Accessory Incompatibility; Detachment of Device or Device Component; Human-Device Interface Problem; Component or Accessory Incompatibility; Detachment of Device or Device Component; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC PROCEDURE INVOLVING OVERSEWING THE ANASTOMOSIS OF THE GASTROJEJUNOSTOMY AND JEJUNOJEJUNOSTOMY, THE INSTRUMENT WAS DIFFICULT TO LOAD AND DID NOT FEEL SMOOTH DURING NEEDLE TRANSFERS, WITH THE SURGEON DESCRIBING A "CRUNCH" FEEL RATHER THAN THE NORMAL SMOOTH ACTION. DURING LOADING, THE JAWS OF THE INSTRUMENT CLOSED ON THE NEEDLE AND LOCKED IT IN PLACE, BUT UPON RELEASING THE HANDLE, THE JAWS POPPED OPEN AND RELEASED THE NEEDLE ONTO THE BACK TABLE. THE ISSUE WAS RESOLVED BY USING ANOTHER LOADING UNIT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000717 ↗
• MalfunctionAug 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC HIATAL HERNIA, WHEN USING THE INSTRUMENT, THE NEEDLE FELL INTO THE CAVITY OF THE PATIENT AND WAS ABLE TO BE RETRIEVED BY USING A LAPAROSCOPIC GRASPER. ANOTHER RELOAD WAS OPENED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19919152 ↗
• InjuryApr 20, 2023Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHILE SUTURING THE OMENTUM, THE DEVICE WAS DIFFICULT TO TOGGLE. THE NEEDLE FELL INTO THE CAVITY AND WERE RETRIEVED WITH GRASPERS. X-RAY WAS PERFORMED FOR THE EXPRESS PURPOSE OF LOCATING THE COMPONENT, OR CONFIRMING THAT ALL PIECES WERE LOCATED. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 16778225 ↗
• MalfunctionNov 1, 2021Entrapment of Device; Component or Accessory Incompatibility; Human-Device Interface Problem; Entrapment of Device; Component or Accessory Incompatibility; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC BYPASS WHILE BEING APPLIED ON THE STOMACH, THE DEVICE WAS DIFFICULT TO TOGGLE, LOAD, UNLOAD, AND THE TISSUE KEPT GETTING STUCK IN THE JAWS WHILE TOGGLING THE NEEDLE BETWEEN JAWS. THE SURGEON CONTINUED TO USE THE DEVICE WITH SOME DIFFICULTY BUT WAS ABLE TO FINISH THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12728693 ↗
• MalfunctionJun 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A GASTRIC BYPASS, THE NEEDLE BROKE OFF THE SUTURE. IT WAS STATED THAT THE NEEDLE WAS NOT SEWED ON PROPERLY. ANOTHER SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11998542 ↗
• MalfunctionJun 1, 2021Break; Break

  ACCORDING TO THE REPORTER, WHEN THE SUTURE WAS BEING APPLIED THROUGH THE CRUA IN A LAPAROSCOPIC PARAESOPHAGEAL HERNIA REPAIR, THE NEEDLE BROKE IN HALF. THE SURGEON HAD TO REMOVE THE NEEDLE COMPONENTS AND RE-DO CLOSURE OF THE CRUA. THIS EXTENDED 45 MINUTES TO PROCEDURE TIME. SURGEON OPENED A SECOND DEVICE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11916207 ↗
• MalfunctionMay 27, 2021Detachment of Device or Device Component; Human-Device Interface Problem; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, ON LAPAROSCOPIC DUODENAL SWITCH, WHILE CLOSING THE ENTEROTOMY, THE DEVICE WAS DIFFICULT TO TOGGLE BACK AND FORTH. THE NEEDLE ALSO FELL OUT OF JAWS AND FELL INTO THE STOMACH OF THE PATIENT. THE NEEDLE WAS PULLED OUT OF THE STOMACH WITH A GRASPER. A NEW DEVICE WAS OPENED AND TOOK ONE BITE AND THE NEEDLE FELL OUT AGAIN. ANOTHER DEVICE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893370 ↗
• InjuryApr 23, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING THORACO/ ESOPHAGUS PROCEDURE, WHILE SUTURING, THE NEEDLE BROKE AT THE CENTER. THE SURGEON SAID THAT THE DEVICE WAS USED AS USUAL AND THE TISSUE WAS NEITHER TOO THICK NOR HARD. THE PART FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. THE INCISION SITE WAS EXTENDED BY MORE THAN 3 CM AND SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES. TISSUE DAMAGE WAS ALSO NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 7451204 ↗
• MalfunctionApr 12, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA PROCEDURE, WHILE SUTURING, THE NEEDLE CAME OFF FROM THE SUTURE. THE REST OF THE SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY IN THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7427363 ↗
• MalfunctionMar 6, 2018Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC ESOPHAGECTOMY PROCEDURE. DURING THE ESOPHAGEAL WRAP, THE SUTURE STRAND KEPT BREAKING WHILE THE SURGEON WAS TRYING TO TIE THE KNOT. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, OPENED ANOTHER BOX OF SUTURE. THERE WAS NO PATIENT HARMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7318722 ↗
• InjuryOct 2, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, THE NEEDLE BROKE IN THE CAVITY AND COULDN'T BE RETRIEVED RIGHT AWAY. THE DOCTOR HAD TO PERFORM X-RAYS TO FIND THE NEEDLE AND IT WAS EVENTUALLY RETRIEVED. SURGERY TIME WAS EXTENDED OVER 30 MINUTES AND THERE WAS VERY LITTLE BLOOD LOSS. THE PATIENT IS CURRENTLY FINE.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 6908524 ↗
• MalfunctionOct 2, 2017Break; Detachment Of Device Component; Human-Device Interface Problem; Break; Detachment Of Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROUX-EN-Y PROCEDURE, DURING A HIATAL HERNIA REPAIR WHEN STITCHING INTO THE POSTERIOR CRUSE, THE DEVICE WAS FOUND TO BE DIFFICULT TO UNLOAD BUT REMAINED FUNCTIONAL FOR ADDITIONAL RELOADS. AT ONE POINT, THE NEEDLE BROKE AND PART OF THE NEEDLE FELL INTO THE CAVITY. THE BROKEN NEEDLE WAS RETRIEVED WITH GRASPERS WHICH WERE ALSO USED TO REMOVE THE PIECE THAT WAS STUCK IN THE DEVICE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE DEVICE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6907762 ↗

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