Surgitie SGL-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521099531), received between Sep 20, 2017 and Aug 23, 2022 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, WHEN LIGATING THE APPENDIX, THE THREE SUTURES BROKE ONCE THE SURGEON PULLED TO LIGATE. THE DEVICE WAS USED IMMEDIATELY AFTER OPENING FROM THE PACKAGE. A NEW SUTURE FROM THE SAME BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15277921 ↗
• MalfunctionJul 12, 2022Break; Break

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC APPENDECTOMY, WHILE IN THE APPENDIX, THE SUTURE BROKE. ANOTHER DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14989144 ↗
• MalfunctionJun 2, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC MYOMECTOMY, THE THREAD BROKE. ANOTHER SUTURE WAS USED 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 14575240 ↗
• MalfunctionMay 31, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN SURGERY, BEFORE USE, TWO SUTURES HAD BROKEN ROPES. ANOTHER SUTURE WAS USED 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 14549339 ↗
• MalfunctionAug 4, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY, THE LINE STUCK AND THE THREAD BROKE. MEANWHILE, THE THREE RELOADS FOR MANUAL HANDLE WOULD NOT CLOSE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12275126 ↗
• MalfunctionMay 27, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, WHEN TYING THE LOOP, THE THREAD SNAPPED. ANOTHER PACKAGE WAS USED 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 11891775 ↗
• MalfunctionFeb 23, 2021Break; Break

  ACCORDING TO THE REPORTER, WHILE DOING LAPAROSCOPIC APPENDECTOMY, THE SUTURE THREAD BROKE DURING TYING. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364749 ↗
• MalfunctionDec 19, 2019Break; Break

  ACCORDING TO THE REPORTER, WHILE BEING APPLIED IN THE MESOAPPENDIX DURING LAPAROSCOPIC APPENDECTOMY, THE SURGEON PERFORMED KNOT PUSHER TECHNIQUE AND THE SUTURE WAS BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9497194 ↗
• MalfunctionOct 25, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, THE NEEDLE BROKE AND FELL INTO THE PATIENT'S CAVITY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240676 ↗
• MalfunctionOct 17, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, DURING LIGATION OF APPENDIX, WHILE THE SURGEON ONLY NEED TO PULL TO COMPLETE THE THROW, THE THREAD OF THE DEVICE BROKE. SURGEON USED ANOTHER DEVICE TO COMPLETE THE CASE. NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9203162 ↗
• MalfunctionJul 8, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE WHILE LIGATING THE VESSEL IN THE CYSTIC DUCT, THE LOOP CANNOT BE PUSHED AND DIFFICULT TO TIGHTEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8767601 ↗
• MalfunctionOct 31, 2018Break; Break

  ACCORDING TO THE REPORTER, WHEN STITCHING THE SKIN TO CLOSE THE WOUND ON AN OPEN PROCEDURE, THE THREAD BROKE. THE PHYSICIAN USED ANOTHER NEW SAME TYPE OF PRODUCTS TO COMPLETE THE OPERATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8023833 ↗
• MalfunctionAug 15, 2018Break; Break

  ACCORDING TO THE REPORTER, THE THREAD BROKE WHILE LIGATING APPENDICULAR ARTERY DURING A LAPAROSCOPY PROCEDURE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7786296 ↗
• MalfunctionJul 5, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, WHEN APPLYING THE DEVICE TO LIGATE THE MESOAPPENDIX VESSEL IN APPENDECTOMY, THE SURGEON BROKE THE TIP OF THE NEEDLE WHEN APPLYING THE KNOT AS USUAL, BUT IT DIDN'T MOVE. THEY REPLACED THE DEVICE WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7663493 ↗
• MalfunctionMar 29, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE SURGEON PERFORMED SUTURING TECHNIQUE, THE THREAD OF THE DEVICE WAS BROKEN. NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. PATIENT HAS NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7383230 ↗
• MalfunctionMar 26, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, TEN MINUTES INTO THE PROCEDURE, THE THREAD BROKE. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7371992 ↗
• MalfunctionMar 23, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, THE DEVICE¿S THREAD BROKE WHILE BEING USE TO LIGATE APPENDIX. NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7367727 ↗
• MalfunctionDec 6, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR PROCEDURE, THE THREAD BROKE. AN ADDITIONAL SUTURE WAS USED WITHOUT AN ISSUE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7086562 ↗
• MalfunctionOct 26, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHILE AT THE MOMENT OF LIGATION, AND USING THE NONE LOOP SUTURING TECHNIQUE, THE THREAD OF THE ABSORBABLE SUTURE BROKE. IT WAS OPENED 5 MINUTES PRIOR TO USE. THEY REPLACED IT WITH THE SAME KIND OF PRODUCT TO COMPLETE THE CASE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6979356 ↗
• MalfunctionSep 20, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, WHILE LIGATING THE APPENDIX, THE DEVICE¿S THREAD BROKE. A NEW DEVICE WAS USED IN ORDER TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6880719 ↗