SILS Stitch SILSSTITCHRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521100022), received between Jul 30, 2018 and Jul 12, 2022 — classified as 1 injury, 1 malfunction.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 12, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTROPATHY ON A DOG, WHEN REUSING A DISPOSABLE DEVICE, THE NEEDLE CRACKED IN HALF. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14993519 ↗
• InjuryJul 30, 2018Break; Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY, ON VAGINAL CUFF CLOSURE, THE NEEDLE KEPT BREAKING, WHICH ADDED AT LEAST AN HOUR TO THE PATIENT¿S SURGERY. THE NEEDLE FELL INTO THE PATIENT¿S CAVITY. IT WAS RETRIEVED VIA A LAPAROSCOPIC GRASPING DEVICE BUT EXTENDED THE CASE SIGNIFICANTLY AND THE SURGEON ENDED UP CLOSING THE VAGINAL CUFF VIA HAND STITCH THROUGH THE VAGINAL VAULT TO COMPLETE THE CASE. THE PROCEDURE WAS CONVERTED TO OPEN DUE TO THE DEVICE PROBLEM.

  Patient problems: No Code Available

  MAUDE report 7731144 ↗