ENDOLOOP EZ10GRecalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 10705031206427), received between Jun 12, 2019 and Apr 21, 2026 — classified as 8 injuries, 118 malfunctions.

The most frequently reported specific device problem is “Break” (59 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 25 most recent of 126 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC APPENDECTOMY ON 1-APR-2026 AND SUTURE WAS USED ON THE APPENDIX. DURING THE PROCEDURE, THE SUTURE BROKE WHILE TIGHTENING THE LOOP. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICE WILL BE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940596 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE OPERATION, A RUPTURE OCCURRED WHILE USING THE APPENDICEAL LIGATOR. CHANGED ANOTHER ONE TO COMPLETE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24705821 ↗
• MalfunctionMar 6, 2026Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PEDIATRIC SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE CAME OFF (SLIPPED OUT) WHEN THE BREAK POINT WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533121 ↗
• MalfunctionFeb 27, 2026Break; Product Quality Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A SUTURE LOOP WAS USED. HAD A PROBLEM WITH OUR ENDOLOOP I HAVE THE PACKAGES AND THE REST OF THE BOX TO RETURN TO THE COMPANY FOR THEM TO CHECK. THE ONE STUCK WHILE TRYING TO DEPLOY THEN THE LOOP BROKE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470159 ↗
• MalfunctionJan 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE LIGATURE BROKE DURING THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028508 ↗
• MalfunctionJan 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE LIGATURE BROKE DURING THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028404 ↗
• MalfunctionDec 31, 2025Break; Product Quality Problem; Break; Product Quality Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, NURSE MENTIONED SOMETHING ON THE STRAND BROKE OFF AND THE STRAND CANNOT BE PULLED. SUTURE WAS BROKEN. PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936135 ↗
• MalfunctionNov 20, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THAT THERE WERE MULTIPLE FAILURES. THE FIRST DEVICE BROKE OFF, THE SECOND AND THIRD WITH FLIMSY COMPONENTS. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606629 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THAT THERE WERE MULTIPLE FAILURES. THE FIRST DEVICE BROKE OFF, THE SECOND AND THIRD WITH FLIMSY COMPONENTS. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606624 ↗
• MalfunctionNov 20, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THAT THERE WERE MULTIPLE FAILURES. THE FIRST DEVICE BROKE OFF, THE SECOND AND THIRD WITH FLIMSY COMPONENTS. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606620 ↗
• MalfunctionOct 10, 2025Delivered as Unsterile Product; Device Markings/Labelling Problem; Delivered as Unsterile Product; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REPRESENTATIVE REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A HOLE WAS OBSERVED IN THE PACKAGING, PREVENTING VALIDATION OF STERILITY. NO PATIENT WAS INVOLVED. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23270411 ↗
• MalfunctionOct 10, 2025Delivered as Unsterile Product; Device Markings/Labelling Problem; Delivered as Unsterile Product; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REPRESENTATIVE REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A HOLE WAS OBSERVED IN THE PACKAGING, PREVENTING VALIDATION OF STERILITY. NO PATIENT WAS INVOLVED. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23270397 ↗
• MalfunctionOct 10, 2025Delivered as Unsterile Product; Device Markings/Labelling Problem; Delivered as Unsterile Product; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REPRESENTATIVE REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A HOLE WAS OBSERVED IN THE PACKAGING, PREVENTING VALIDATION OF STERILITY. NO PATIENT WAS INVOLVED. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23270392 ↗
• MalfunctionSep 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC APPENDECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING A LAPAROSCOPIC APPENDECTOMY, THE SUTURE CAME OFF WHEN TRIED TO LIGATURE AND THE TIP OF THE CANULA AT THE BREAK POINT WAS BROKEN. IT WAS USED ON APPENDIX. ANOTHER DEVICE WAS USED AND TRIED THE SAME OPERATION, BUT THE SUTURE CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. TWO DEVICES WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23158308 ↗
• MalfunctionSep 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC APPENDECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING A LAPAROSCOPIC APPENDECTOMY, THE SUTURE CAME OFF WHEN TRIED TO LIGATURE AND THE TIP OF THE CANULA AT THE BREAK POINT WAS BROKEN. IT WAS USED ON APPENDIX. ANOTHER DEVICE WAS USED AND TRIED THE SAME OPERATION, BUT THE SUTURE CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. TWO DEVICES WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23158302 ↗
• MalfunctionSep 26, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRAUMA PROCEDURE IN 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED TO THE DL PER SALES REP, THEY WERE COMPLAINING OF WHOLES BEING IN THE PRODUCT. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23157072 ↗
• MalfunctionSep 25, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRAUMA PROCEDURE IN 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED TO THE DL PER SALES REP, THEY WERE COMPLAINING OF WHOLES BEING IN THE PRODUCT. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23145138 ↗
• MalfunctionSep 25, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRAUMA PROCEDURE IN 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED TO THE DL PER SALES REP, THEY WERE COMPLAINING OF WHOLES BEING IN THE PRODUCT. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23145137 ↗
• MalfunctionSep 25, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRAUMA PROCEDURE IN 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED TO THE DL PER SALES REP, THEY WERE COMPLAINING OF WHOLES BEING IN THE PRODUCT. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23145136 ↗
• MalfunctionSep 25, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRAUMA PROCEDURE IN 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED TO THE DL PER SALES REP, THEY WERE COMPLAINING OF WHOLES BEING IN THE PRODUCT. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23145108 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC APPENDECTOMY FOR APPENDICITIS ON (B)(6) 2025 AND SUTURE WAS USED. DURING USE ON THE PATIENT, WHEN FOLDED THE BREAK POINT AND PULLED THE CANNULA, THE SUTURE CAME LOOSE, SO IT COULD NOT BE PULLED THE CANNULA. THE DEVICE WAS ABOUT TO BE USED ON THE RADIX OF APPENDIX. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22867019 ↗
• MalfunctionJul 17, 2025Break; Delivered as Unsterile Product; Break; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. AFTER OPENING THE PACKAGE, WHEN THE NURSE TOOK OUT THE PRODUCT FROM THE PACKAGE AND HANDED OVER TO THE DOCTOR, THE SUTURE BROKE AT THE ROOT OF THE LOOP AND THE BREAK POINT ALSO BROKE ALONG WITH THE SUTURE. WHEN THE SALES REP CONFIRMED THE PACKAGE, THERE WERE MULTIPLE HOLES IN IT, BUT IT WAS NOT DETERMINED WHETHER THESE HAD OCCURRED WHEN THE DOCTOR CARRIED THE PRODUCT AFTER THE EVENT OCCURRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22533031 ↗
• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY ON AN UNKNOWN DATE, WHEN THE BREAK POINT CHANNEL WAS BROKEN, THE SUTURE BROKE. SINCE IT WAS OUTSIDE THE BODY CAVITY, THE DOCTOR ASSUMED THAT THERE WAS NO PROBLEM AND CONTINUED TO USE IT, BUT THE KNOT DID NOT MOVE TO CLOSE THE LOOP EVEN WHEN PRESSED THE CANNULA, SO THE DOCTOR DECIDED IT WAS A DEFECTIVE PRODUCT AND REPLACED IT WITH A REPLACEMENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22110375 ↗
• MalfunctionMay 23, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A APPENDICITIS SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PRODUCT COULD NOT BE TIGHTENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT . NO ADDITIONAL INFORMATION CAN BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079605 ↗
• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE WHILE PULLING. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036755 ↗