Surgitie SGL-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521099463), received between Jan 4, 2022 and Jan 15, 2025 — classified as 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2025Break; Break

  IT WAS REPORTED THAT PRIOR TO THE USE OF THE SGL-3 CHROMIC GUT SUTURE, THE SUTURE BROKE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159309 ↗
• MalfunctionJan 4, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE PERFORMING A LOOP AT THE PANCREAS DURING A LAPAROSCOPIC PANCREATOMY, THE THREAD BROKE AND A COMPONENT FELL INTO PATIENT'S CAVITY. THIS OCCURRED THREE TIMES. THE SURGEON WAS ABLE TO RETRIEVE THE COMPONENT AND THE SUTURE WAS REPLACED BY A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13154944 ↗