SurgitieRecalls & reported problems across all models

We found 6 models of Surgitie by Covidien LP in the FDA's device registry (GUDID). Together they are named in 65 adverse event reports in the FDA's MAUDE database, received between Jul 25, 2017 and Sep 15, 2026 — classified as 3 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Break” (36 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Surgitie problems

Surgitie models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Surgitie SGL-1

  SUTURE, ABSORBABLE, NATURAL
  20 reports
• Surgitie EL-21-L

  SUTURE, ABSORBABLE, NATURAL
  20 reports
• Surgitie EL-20-L

  SUTURE, ABSORBABLE, NATURAL
  14 reports
• Surgitie ED-20-L

  SUTURE, ABSORBABLE, NATURAL
  6 reports
• Surgitie EL-23-LN

  SUTURE, ABSORBABLE, NATURAL
  3 reports
• Surgitie SGL-3

  SUTURE, ABSORBABLE, NATURAL
  2 reports

Recent Surgitie adverse event reports

The 15 most recent reports across all models, 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 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionOct 2, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN THE TISSUE WAS LOOPED AND THE SUTURING WAS ABOUT TO BEGIN, THE CANNULA GOT STUCK AND COULD NOT BE ADVANCED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352451 ↗
• 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 ↗
• 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 ↗

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