Surgitie EL-20-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521099647), received between Aug 6, 2017 and Oct 2, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJun 2, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING APPENDECTOMY SURGERY, TWO UNITS WERE USED WITH IMPOSSIBILITY OF TIGHTENING THE SUTURE. A THIRD ONE WAS USED BY THE SURGEON WITH A DIFFERENT LOT NUMBER FROM THE FIRST TWO TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052191 ↗
• MalfunctionAug 16, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE COULD NOT MOVE AFTER TRAPPING THE APPENDIX..

  Patient problems: Insufficient Information

  MAUDE report 12328010 ↗
• MalfunctionJun 8, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, THE SUTURE JAMMED AND LOOP OVER APPENDIX COULD NOT BE COMPLETED. ANOTHER DEVICE 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 11962793 ↗
• MalfunctionMay 26, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, WHEN LIGATED THE APPENDIX DURING A LAPAROSCOPIC APPENDECTOMY, THE SUTURE COULD NOT BE TIED WELL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10085876 ↗
• MalfunctionDec 10, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN TIGHTENING THE SUTURE AS USUAL, IT STOPPED MOVING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9444992 ↗
• MalfunctionDec 10, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN TIGHTENING THE SUTURE AS USUAL, IT STOPPED MOVING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9444930 ↗
• MalfunctionOct 22, 2019Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE THREAD BROKE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9218451 ↗
• MalfunctionAug 1, 2018Difficult to Open or Close; Physical Resistance/Sticking; Difficult to Open or Close

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC APPENDECTOMY, THERE WAS A STRONG RESISTANCE WHEN PULLING THE STRING, SO THE LOOP COULD NOT BE NARROWED AND THE LIGATION COULD NOT BE COMPLETED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7739108 ↗
• MalfunctionMay 15, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING APPENDECTOMY, THE SURGEON APPLIED THE SUTURE LOOP ONTO THE TISSUE AND TRIED TO DRAW IT TIGHT, HOWEVER, THE LOOP COULD NOT BE TIGHTEN BUT IT GOT TANGLED. A NEW DEVICE WAS OPENED BUT SAME RESULT HAPPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7515413 ↗
• MalfunctionDec 27, 2017Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE OF APPENDECTOMY, INSTALLATION OF 2 ENDOLOOPS ON AN APPENDIX OVERSIZED ON IT S DISTAL PART. FOR THE 2ND ENDOLOOP, THE THREAD LOOP COULD NOT BE TIED AROUND THE APPENDIX. ANOTHER ENDOLOOP HAS BEEN USED. TO RESOLVE AND COMPLETE THE CASE, ANOTHER ENDOLOOP HAS BEEN USED. THE INCISION WAS EXTENDED DUE TO THE PRODUCT PROBLEM. THE OPERATING TIME GOT INCREASED BUT IT UNKNOWN BY HOW MUCH. PATIENT OUTCOME UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7150006 ↗
• MalfunctionOct 10, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE DEVICE¿S LOOP DID NOT WORK PROPERLY. THE THREAD OF THE BROKE. ANOTHER NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6934096 ↗
• MalfunctionSep 15, 2017Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, THE THREAD TWISTED, IT DID NOT BECOME THE SHAPE OF A LOOP. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6870313 ↗
• MalfunctionAug 6, 2017Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC APPENDICITIS PROCEDURE. THE SURGEON WAS EMPLOYING THE SEAM TECHNIQUE. THE KNOT WAS NOT ABLE TO BE PUSHED. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, REPLACED WITH A NEW PUSHER. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6769922 ↗