Syneture US1560Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521160989), received between Jan 9, 2024 and Jan 9, 2024 — classified as 1 injury.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2024Break; Unraveled Material; Break; Unraveled Material

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, FOLLOWING AN OPEN ABDOMINAL PROCEDURE TO REMOVE A LARGE OVARIAN MASS, THE PATIENT RETURNED TO THE EMERGENCY ROOM WITH HER SMALL BOWEL EXPOSED BECAUSE THE SUTURE DID NOT HOLD. IT WAS NOTED THAT THE SUTURE WAS BROKEN. TO RESOLVE THE ISSUE, ADDITIONAL SURGERY WAS PERFORMED TO CLOSE THE WOUND.

  Patient problems: Bowel Perforation; Wound Dehiscence

  MAUDE report 18480962 ↗