Surgitie EL-21-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521099630), received between Dec 6, 2017 and Sep 15, 2026 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break

  It was reported that preoperatively, upon opening the packaging prior to removal, the suture was broken. An additional new suture was used without issue. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766527 ↗
• MalfunctionMar 3, 2026Difficult to Open or Close

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN THE SUTURE WAS USED TO PUSH IN THE KNOT AT THE LIGATION SITE, IT COULD NOT BE PUSHED IN. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496839 ↗
• MalfunctionJun 17, 2025Break; Break

  IT WAS REPORTED THAT THE SUTURE BROKE UPON OPENING THE PACKAGING PRIOR TO REMOVAL, SPECIFICALLY IN THE MIDDLE OF THE SUTURE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22225516 ↗
• MalfunctionJun 10, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE STRING COULD NOT BE TIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177944 ↗
• MalfunctionSep 19, 2024Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING AN APPENDECTOMY PROCEDURE, THE SUTURE WAS STUCK AND COULD NOT BE TIGHTENED. IT WAS NOTED THAT THE SUTURE BROKE. THE SURGEON OPENED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20262801 ↗
• InjuryApr 16, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, 2 DAYS POSTOPERATIVELY, OF AN LAPAROSCOPIC APPENDECTOMY PROCEDURE, WHEN THE DEVICE USED TO CLOSE THE APPENDIX, THERE WAS A RELEASE OR THE LOOPS LOOSENED FOR THE THREE SYNTHETIC LIGATURE LOOPS DUE TO THE APPENDECTOMY, WHICH RESULTED IN PERITONITIS. IT WAS NOTED THAT IT WAS VERY PAINFUL FOR THE PATIENT. TO RESOLVE THE ISSUE, ADDITIONAL SURGERY FOR CLOSURE OF THE APPENDICULAR STUMP WAS DONE BY STAPLING.

  Patient problems: Pain

  MAUDE report 19117676 ↗
• InjuryMar 12, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, TWO DAYS POSTOPERATIVELY OF AN LAPAROSCOPIC APPENDECTOMY PROCEDURE, WHEN THE DEVICE WAS USED TO CLOSE THE APPENDIX, THERE WAS A RELEASE OR THE LOOPS LOOSENED FOR THE THREE SYNTHETIC LIGATURE LOOPS DUE TO THE APPENDECTOMY WHICH RESULTED IN PERITONITIS. IT WAS NOTED THAT IT WAS VERY PAINFUL FOR THE PATIENT. TO RESOLVE THE ISSUE, ADDITIONAL SURGERY FOR CLOSURE OF THE APPENDICULAR STUMP WAS DONE BY STAPLING.

  Patient problems: Pain

  MAUDE report 18891244 ↗
• InjuryMar 12, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, 2 DAYS POSTOPERATIVELY, OF AN LAPAROSCOPIC APPENDECTOMY PROCEDURE, WHEN THE DEVICE USED TO CLOSE THE APPENDIX, THERE WAS A RELEASE OR THE LOOPS LOOSENED FOR THE THREE SYNTHETIC LIGATURE LOOPS DUE TO THE APPENDECTOMY, WHICH RESULTED IN PERITONITIS. IT WAS NOTED THAT IT WAS VERY PAINFUL FOR THE PATIENT. TO RESOLVE THE ISSUE, ADDITIONAL SURGERY FOR CLOSURE OF THE APPENDICULAR STUMP WAS DONE BY STAPLING.

  Patient problems: Pain

  MAUDE report 18891201 ↗
• MalfunctionFeb 7, 2024Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO A LAPAROSCOPIC APPENDECTOMY, THE SUTURE BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18661499 ↗
• MalfunctionDec 15, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, WHEN OPENING THE PACKAGING, THE THREAD WAS BROKEN. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18339098 ↗
• MalfunctionDec 13, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HEPATECTOMY SURGERY, AT THE TISSUE BEING USED FOR LIGATION, THE THREAD BROKE WITHIN 30 MINUTES WHEN THE SUTURE WAS USED. IT WAS NOTED THAT THE ABSORBABLE SUTURE DID NOT GO BEYOND THE DEVICE AT THE TIP AND BROKE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18321350 ↗
• MalfunctionApr 7, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD WOULD NOT PULL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704493 ↗
• MalfunctionMay 25, 2022Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC PROCEDURE, IT WAS NOT POSSIBLE TO SLIDE THE KNOT FROM THE LIGATION LOOP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14500314 ↗
• MalfunctionMar 1, 2022Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE SUTURE WAS NOT WORKING PROPERLY. THE SUTURE FORMS A LOOP WHEN IT WAS BEING TIGHTENED AND IT TAKES AN END OF THE INTESTINE THAT WAS NOT INTENDED.

  Patient problems: Insufficient Information

  MAUDE report 13635612 ↗
• MalfunctionJan 5, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN APPENDECTOMY PROCEDURE, WHILE TYING THE APPENDIX STUMP, THE KNOT WAS SEATED ON STUMP AND KNOT DID NOT SLIP TOWARDS THE TISSUE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11118426 ↗
• MalfunctionAug 13, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN APPENDECTOMY, ON ENDOSCOPIC SUTURING, THE SHAFT THAT CONNECTS THE SUTURE WAS BROKEN UPON OPENING THE PACKAGE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10402815 ↗
• MalfunctionJun 3, 2020Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE NEEDLE BROKE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10114551 ↗
• MalfunctionSep 17, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC PROCEDURE, THE NEEDLE GOT BROKE. IN ORDER TO COMPLETE THE CASE, THEY REPLACED BY ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7880840 ↗
• MalfunctionMay 11, 2018Break; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING AN LAPAROSCOPIC APPENDECTOMY PROCEDURE TO TREAT A PATIENT WITH ACUTE APPENDICITIS. THE DEVICE WAS BROKEN BEFORE USE. NO PATIENT INJURY OR EXTENSION IN SURGICAL TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7507639 ↗
• MalfunctionDec 6, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR A PROCEDURE, THE SUTURE WAS DETACHED FROM THE INSTRUMENT ONCE THE NURSE OPENED IT TO GIVE IT TO THE SURGEON IN THE OPERATION ROOM. PRODUCT WAS NOT USED ON A PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7088125 ↗