Surgitie ED-20-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521099661), received between Aug 15, 2017 and Mar 4, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDICEAL LIGATION PROCEDURE, THE PULL RING ROD OF THE DEVICE WAS DAMAGED. LIGATION WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507136 ↗
• MalfunctionJun 11, 2021Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER, DURING APPENDECTOMY PROCEDURE, THE DEVICE'S DISPOSABLE SNARE WIRE KNOT FELL OFF. THE SURGEON THEN USED ANOTHER DEVICE 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 11988101 ↗
• MalfunctionFeb 12, 2021Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER, THE DISPOSABLE TRAP THREAD WAS USED TO LIGATE THE ROOT OF THE APPENDIX, AND THE DISPOSABLE TRAP THREAD KNOT FELL OFF. ANOTHER PRODUCT WAS USE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11320875 ↗
• MalfunctionJan 29, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ENDOSCOPIC APPENDIX SURGERY, ON LIGATION OF THE APPENDIX, THE DEVICE'S TRAP CAUGHT THE TAIL AND COULD NOT BE DRAWN OUT. THEY REPLACED WITH ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9641472 ↗
• MalfunctionSep 20, 2017Break; Break

  ACCORDING TO THE REPORTER, ON (B)(6) 2017, INTRA-OPERATIVELY, THE DEVICE WAS BROKEN. A NEW UNIT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6880185 ↗
• MalfunctionAug 15, 2017Break; Break

  ACCORDING TO THE REPORTER, THE DEVICE'S THREAD WAS BROKEN. NO PATIENT INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6794806 ↗