Endo Clip 176620Recalls & reported problems

Summary

The FDA's MAUDE database contains 254 adverse event reports that list this exact device (DI 10884521057876), received between Jul 15, 2016 and Nov 27, 2024 — classified as 16 injuries, 238 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (144 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 25 most recent of 254 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC CHOLECYSTECTOMY, WHILE IN THE BLOOD VESSEL, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE BUT THERE WAS AN ISSUE WITH THE LOADING OR FIRING OF THE CLIPS. HALF CLIPPING WAS NOT POSSIBLE WHEN CLIPPING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20802805 ↗
• MalfunctionJan 4, 2024Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE DEVICE WAS BEING INTO THE BLOOD VESSEL, THE CLIP COULD NO LONGER BE LOADED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18446870 ↗
• MalfunctionJun 2, 2023Difficult to Remove; Difficult to Open or Close; Difficult to Remove; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, DURING TISSUE LIGATION, THE JAWS OF THE CLIP APPLIER WAS UNABLE TO CLOSE, THEREFORE SURGEON WAS UNABLE TO REMOVE IT THROUGH THE FIVE MILLIMETER PORT. THE DEVICE WAS REMOVED FROM THE FIELD AND THE FIVE MILLIMETER PORT WAS REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052679 ↗
• MalfunctionMay 5, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC LIGATURE OF THE VESSEL, THERE WERE  ISSUES EXPERIENCED WITH THE LOADING OR FIRING OF THE CLIPS. NO CLIPS WERE ABLE TO LOAD PROPERLY INTO THE JAWS AT ANY POINT DURING USE. THE CLIP APPLIER WAS CHANGED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16881905 ↗
• MalfunctionMar 22, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SURGEON WAS ABLE TO SQUEEZE THE JAWS TOGETHER TO FIRE A FIRST CLIP AND THEN NOTHING AFTER, UNABLE TO SQUEEZE THE JAWS WITH THE HANDLE. ANOTHER CLIP APPLIER WAS USED, HOWEVER SAME SCENARIO OCCURRED. THE CLIPS WERE NOT ABLE TO LOAD PROPERLY INTO THE JAWS. THIRD CLIP APPLIER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590717 ↗
• MalfunctionMar 21, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE MISFIRED AND STOPPED WORKING. THE CLIPS WERE NOT ABLE TO LOAD PROPERLY INTO THE JAWS. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583070 ↗
• MalfunctionMar 20, 2023Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING AN INGUINAL HERNIA LAPAROSCOPY, THE CLIP DID NOT CLOSE. ANOTHER DEVICE WAS USED FOR STAPLING TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16576495 ↗
• MalfunctionFeb 8, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC SYMPATHECTOMY, WHILE IN THE VESSEL NEAR THE SYMPATHIC NERVE, THE TWO CLIP APPLIERS FROM THE SAME LOT AND ONE FROM ANOTHER LOT STOPPED FIRING. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE BUT THERE WERE ISSUES WITH LOADING OR FIRING THE CLIPS. THE FIRST CLIP APPLIER SHOT ONE CLIP AND THEN LOCKED. THE SECOND CLIP APPLIER SHOT TWO CLIPS, THEN THE DEVICE LOCKED. THE THIRD CLIP APPLIER LOCKED AFTER SHOOTING 1 CLIP. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16322566 ↗
• MalfunctionFeb 7, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC SYMPATHECTOMY, WHILE IN THE VESSEL NEAR THE SYMPATHIC NERVE, THE TWO CLIP APPLIERS FROM THE SAME LOT AND ONE FROM ANOTHER LOT STOPPED FIRING. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE BUT THERE WERE ISSUES WITH LOADING OR FIRING THE CLIPS. THE FIRST CLIP APPLIER SHOT ONE CLIP AND THEN LOCKED. THE SECOND CLIP APPLIER SHOT TWO CLIPS, THEN THE DEVICE LOCKED. THE THIRD CLIP APPLIER LOCKED AFTER SHOOTING 1 CLIP. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315438 ↗
• MalfunctionFeb 7, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC SYMPATHECTOMY, WHILE IN THE VESSEL NEAR THE SYMPATHIC NERVE, THE TWO CLIP APPLIERS FROM THE SAME LOT AND ONE FROM ANOTHER LOT STOPPED FIRING. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE BUT THERE WERE ISSUES WITH LOADING OR FIRING THE CLIPS. THE FIRST CLIP APPLIER SHOT ONE CLIP AND THEN LOCKED. THE SECOND CLIP APPLIER SHOT TWO CLIPS, THEN THE DEVICE LOCKED. THE THIRD CLIP APPLIER LOCKED AFTER SHOOTING 1 CLIP. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315410 ↗
• MalfunctionJan 26, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC APPENDECTOMY, DURING THE DISSECTION OF THE APPENDIX, THE SURGEON PLACED THE CLIP APPLIER AROUND THE APPENDIX BASE AND WAS ABLE TO SQUEEZE THE HANDLE TO LOAD A CLIP, BUT THE CLIP DID NOT ENGAGE PROPERLY IN THE JAWS OF THE DEVICE. THE SURGEON USED ANOTHER CLIP APPLIER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16246009 ↗
• MalfunctionJan 17, 2023Break; Fail-Safe Problem; Break; Fail-Safe Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON WAS NOT ABLE TO SQUEEZE THE HANDLE AND THE CLIP CAME HALFWAY THROUGH, BEING BITTEN IN HALF. ANOTHER PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183940 ↗
• MalfunctionNov 14, 2022Component Missing; Mechanics Altered; Component Missing; Mechanics Altered

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE INDICATOR TURNED RED WHEN THE DEVICE WAS OPENED SO THE HANDLE COULD NOT BE GRIPPED. THE CLIP DID NOT LOAD PROPERLY (DID NOT FULLY COME OUT OF THE DEVICE). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789394 ↗
• MalfunctionOct 5, 2022Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN PANCREATICODUODENECTOMY PROCEDURE, WHEN LIGATION OF SUPERIOR DUODENAL ARTERY, AFTER FIRING, IT FIRED A SHOT AND FOUND NO TITANIUM CLIP INSIDE. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE AND THE CLAMP WAS STILL CLOSED WHEN THE PROBLEM OCCURRED. TO RESOLVE THE ISSUE, IT WAS SWITCH TO ANOTHER DEVICE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15543785 ↗
• MalfunctionSep 2, 2022Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHILE CLIPPING VESSELS, THE CLIPS WOULD MAKE AN X-FORM OVER THE VESSEL. THE SAME DEVICE WAS USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15351057 ↗
• MalfunctionAug 24, 2022Detachment of Device or Device Component; Fail-Safe Problem; Mechanics Altered; Detachment of Device or Device Component; Fail-Safe Problem; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, AFTER LOADING THE CLIP, THE SURGEON COULD NOT CLOSED THE JAWS AND UNABLE TO SQUEEZED THE HANDLE. THE CLIPS WERE NOT LOADING PROPERLY INTO THE JAWS. THE CLIP FELL OUT INTO PATIENT CAVITY AND WAS RETRIEVED USING A GRASPER. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15286955 ↗
• InjuryAug 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, LAPAROSCOPIC BILE DUCT EXPLORATION AND LITHOTOMY, WHILE THE BILE DUCT AND CATHETER WERE TEMPORARILY CLIPPED, IT WAS OBSERVED THAT THE SIDES' LENGTH OF ONE OF THE CLIPS DID NOT MATCH. MRI WAS PERFORMED TO CHECK WHETHER ONE OF THE CLIP TIPS WAS CHIPPED AND WHETHER THE CHIPPED PART WAS INSIDE THE BODY. THE COMPONENT WAS RETRIEVED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 15279434 ↗
• MalfunctionAug 16, 2022Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY FOR OVARIAN CANCER, WHILE CLIPPING A VESSEL, WHEN FIRING THE CLIP OVER THE VESSEL AFTER PRELOADING THE INSTRUMENT, THE DOCTOR NOTICED THAT THE INSTRUMENT WAS NOT CLOSING THE CLIPS PROPERLY AND THAT THEY WERE TWISTING. TRYING TO RESOLVE THE ISSUE, A SECOND CLIP APPLIER WAS OPENED, AND THE DEVICE DID NOT WORK ALSO. A REUSABLE CLIP APPLIER WAS OPENED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15237654 ↗
• MalfunctionAug 16, 2022Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY FOR OVARIAN CANCER, WHILE CLIPPING A VESSEL, WHEN FIRING THE CLIP OVER THE VESSEL AFTER PRELOADING THE INSTRUMENT, THE DOCTOR NOTICED THAT THE INSTRUMENT WAS NOT CLOSING THE CLIPS PROPERLY AND THAT THEY WERE TWISTING. TRYING TO RESOLVE THE ISSUE, A SECOND CLIP APPLIER WAS OPENED, AND THE DEVICE DID NOT WORK ALSO. A REUSABLE CLIP APPLIER WAS OPENED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15237645 ↗
• MalfunctionAug 11, 2022Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPY PROCEDURE, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE AND THE JAWS WAS UNABLE TO CLOSE. THERE WERE ISSUES WITH THE LOADING AND FIRING OF THE CLIPS. THE DEVICE ONLY FIRED ONE CLIP AND WHEN THE SURGEON TRIED TO PLACE A SECOND CLIP IT DID NOT FIRE. A NEW DEVICE WAS REPLACED TO RESOLVE THE CASE. THERE WERE NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15210801 ↗
• MalfunctionJul 26, 2022Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, THE CLIPS WOULD NOT LOAD PROPERLY,THE CLAMP DID NOT CLOSE CLIPS. ANOTHER HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15105024 ↗
• MalfunctionJul 26, 2022Mechanical Problem; Detachment of Device or Device Component; Fail-Safe Problem; Mechanical Problem; Detachment of Device or Device Component; Fail-Safe Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHEN CLOSING THE BILE DUCT, THE NURSE TEST FIRED THE CLIP APPLIER SU CCESSFULLY BEFORE INSERTING TO THE TROCAR, BUT HANDLE COULD NOT BE SQUEEZED WITH THE JAWS OPENED AFTERWARDS. A SECOND CLIP APPLIER WAS USED AND INITIAL FIRE FOR BILE DUCT LIGATION WAS SUCCESSFUL. HOWEVER, ANOTHER CLIP POPPED OUT BEFORE FIRING AND FELL INTO PATIENT CAVITY. THE FALLEN CLIP WAS REMOVED IMMEDIATELY USING FORCEPS AS IT WAS FOUND VISUALLY. THE USER TRIED TO OPERATE THE CLIP HANDLE AGAIN, BUT THE HANDLE BECAME UNABLE TO BE SQUEEZED. THE LIGATION WAS PERFORMED WITH SUTURES INSTEAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15104707 ↗
• MalfunctionJun 27, 2022Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, CYSTIC DUCT AND CYSTIC ARTERY, CLIP FIRED 5 CLIPS AND CLAIMED EMPTY(RED LINE) AND WOULD NOT FIRE ANYMORE CLIPS THEREFORE THE SURGEON COULDN'T FIRE. TO RESOLVE THE ISSUE ANOTHER CLIP APPLIER WAS BROUGHT IN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14836975 ↗
• InjuryJun 9, 2022Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON DESCRIBED NOT FEELING THE CLAMPING FORCE OF THE CLIP WHEN USING THE DEVICE. THE SURGEON HAD DIFFICULTY USING THE CLIP APPLIER. THE CLIP WAS INCORRECTLY POSITIONED CLIP TWICE, HITTING THE ARTERY AND CAUSED A LITTLE BLEEDING (LESS THAN 500CC). THE REMOVAL OF THE CLIPS RESULTED IN A BREACH OF THE CYSTIC ARTERY. A NEW CLIP APPLIER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO TISSUE DAMAGE AND THE PATIENT IS CURRENTLY DOING WELL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 14648557 ↗
• MalfunctionJun 6, 2022Device Slipped; Mechanics Altered; Device Slipped; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE CLIPS DID NOT LOAD PROPERLY INTO THE JAWS AND UPON INSPECTION, IT WAS NOTED THAT THE DEPLOYED CLIPS DID NOT HOLD ON TISSUE. 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 14603009 ↗