PDS Z347HRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031060685), received between Feb 2, 2018 and Apr 13, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

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.

• MalfunctionApr 13, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT LAP HYSTERECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, I WAS ASSISTING DURING A LAPAROSCOPIC HYSTERECTOMY, AND WHILE THE SURGEON WAS PLACING A LAPAROSCOPIC SUTURE TO CLOSE THE VAGINAL CUFF, THE SUTURE BROKE. THE SURGEON DID NOT APPLY ANY EXCESSIVE TENSION TO THE SUTURE. EVERYONE IN THE ROOM WAS SURPRISED BY THIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24862911 ↗
• MalfunctionNov 18, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA PROCEDURE ON (B)(6) 2020, AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF INSIDE OF THE PATIENT. THE FRAGMENTS WERE RETRIEVED. A NEW SUTURE WAS USED TO COMPLETE THE CASE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10860525 ↗
• MalfunctionMay 28, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE OF SUTURE BROKE ON FIRST USE WHEN INSERTING IN THE SUBCUTANEOUS LAYER. THEY WERE UNABLE TO REMOVE THE BROKEN NEEDLE FROM THE PATIENT. AN INTRA-OPERATIVE X-RAY WAS PERFORMED FOR 55 MINUTES. 25 MM OF THE 36MM NEEDLE STILL REMAINS INSIDE THE PATIENT. CASE COMPLETED WITH A DIFFERENT NEEDLE AS THE NEEDLE WAS EMBEDDED IN THE PATIENT. UNSURE OF EXACT NEEDLE AND SUTURE WHICH WAS USED TO CLOSE. THE PATIENT IS AWARE THAT THE NEEDLE STILL REMAINS INSIDE THEIR BODY. THERE IS NO INDICATION THAT THE PATIENT WILL BE RE-ADMITTED TO REMOVE THE NEEDLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Discomfort; No Consequences Or Impact To Patient

  MAUDE report 8647286 ↗
• MalfunctionFeb 28, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A WHIPPLE PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE BROKE FROM THE NEEDLE NEAR THE SWAGE. THE HOSPITAL STAFF OPINED THAT VERY GENTLE PRESSURE IS USED DURING THESE CASES WITH THE NEEDLE HOLDER SO IT IS NOT THOUGHT TO HAVE BEEN CAUSED DURING THE NEEDLE ARMING PROCESS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY IN THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8379797 ↗
• MalfunctionJan 17, 2019Break; Break

  IT WAS FOUND UPON EVALUATION THAT THE NEEDLE WAS BROKEN AT THE SWAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8257751 ↗
• MalfunctionJan 17, 2019Break; Break

  IT WAS FOUND UPON EVALUATION THAT THE NEEDLE WAS BROKEN AT THE SWAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8257744 ↗
• MalfunctionDec 3, 2018Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY PROCEDURE IN 2018 AND A SUTURE WAS USED. DURING SURGERY, THE SUTURE THREAD BECAME DETACHED FROM THE NEEDLE, AND THE END OF THE NEEDLE (WHERE THE SUTURE ATTACHES) BROKE OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8125134 ↗
• MalfunctionFeb 8, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PERIOP PROCEDURE ON (B)(6) 2018, AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN IN TWO PIECES. THE SURGEON WAS ABLE TO REMOVE THE PIECES BEFORE THE END OF THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Code Available

  MAUDE report 7250977 ↗
• MalfunctionFeb 2, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SIGMOIDECTOMY PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. IT WAS REPORTED THAT SUTURE DETACHED FROM THE NEEDLE SWAGE DURING PASSAGE THROUGH TISSUE. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7237308 ↗
• MalfunctionFeb 2, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SIGMOIDECTOMY PROCEDURE ON (B)(4) 2018 AND SUTURE WAS USED. IT WAS REPORTED THAT SUTURE DETACHED FROM THE NEEDLE SWAGE DURING PASSAGE THROUGH TISSUE. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7237296 ↗