PDS Z881GRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031061927), received between May 23, 2018 and May 19, 2025 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE CLOSURE OF THE ABDOMINAL CAVITY WITH SUTURE THE SURGEON NOTICE THE TIP OF THE SUTURE NEEDLE WAS MISSING. THE STAFF REPORTED THAT DR. MENTIONED HEARING A SNAP AND SEEING SOMETHING FLYING. THE MULTIPLE EFFORTS (LOOKING TO THE STERILE FILED DRAPE-ABDOMINAL X-RAY-MAGNET ROLLER ON THE FLOOR-STERILE MAGNET ON THE SURGICAL AREA) TO FOUND THE MISSING PIECE WAS UNFORTUNATELY UNSUCCESSFUL. THE STAFF TOLD REP THIS MORNING THAT THE BROKEN NEEDLE HAS NOT BEEN KEPT AND ALSO THE LOT NUMBER WAS NOT KEPT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046188 ↗
• MalfunctionAug 10, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC TUMOR RESECTION ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE CLOSING THE FASCIA. A NEW SUTURE WAS USED TO COMPLETE THE CASE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12301321 ↗
• InjuryMay 24, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED WOUND CLOSURE DEHISCENCE. THE PATIENT WAS RETURNED TO THE OR FOR ADDITIONAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 7543166 ↗
• InjuryMay 24, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED WOUND CLOSURE DEHISCENCE. THE PATIENT WAS RETURNED TO THE OR FOR ADDITIONAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 7542949 ↗
• InjuryMay 24, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED WOUND CLOSURE DEHISCENCE. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR ADDITIONAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 7542948 ↗
• InjuryMay 24, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED WOUND CLOSURE DEHISCENCE. THE PATIENT WAS RETURNED TO THE OR FOR ADDITIONAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 7542947 ↗
• InjuryMay 24, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED WOUND CLOSURE DEHISCENCE. THE PATIENT WAS RETURNED TO THE OR FOR ADDITIONAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 7542945 ↗
• InjuryMay 23, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED WOUND CLOSURE DEHISCENCE. THE PATIENT WAS RETURNED TO THE OR FOR ADDITIONAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 7539166 ↗