Surgitie EL-23-LNRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521099548), received between Jul 25, 2017 and Jul 5, 2023 — classified as 3 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2023Break; Device Slipped; Break; Device Slipped

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHILE OCCLUDING THE GALL BLADDER BILE DUCT, WHEN THE SUTURE WAS TIGHTENED AND CINCHED DOWN, THE STRAND CUT NEAR THE AREA WHERE THE WHITE PLASTIC CANNULA DISTAL TIP PUSHED DOWN THE KNOT. THE KNOT THEN STARTED TO SLIDE AND LOOSEN. A NEW CLIP APPLIER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17263325 ↗
• MalfunctionMar 4, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, THE SUTURE FAILED TO SLIDE AND THE KNOT DID NOT TIGHTEN AFTER BEING POSITIONED AROUND THE INTENDED STRUCTURE. A NEW SUTURE WAS USED WITHOUT AN ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11412789 ↗
• MalfunctionJul 25, 2017Coiled; Coiled

  ACCORDING TO THE REPORTER, DURING PROCEDURE THE BUCKLE WAS COILED WHEN THE SURGEON WAS TRYING TO REDUCE THE SIZE, NO HARM/INJURY TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6742675 ↗