Endo Clip 176615Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 10884521057807), received between Mar 6, 2018 and Aug 23, 2024 — classified as 10 injuries, 117 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (81 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2024Mechanical Problem; Difficult to Open or Close; Fail-Safe Problem; Mechanical Problem; Difficult to Open or Close; Fail-Safe Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY, THE JAWS OF THE CLIP APPLIER DID NOT CLOSE AND THE CLIPS REMAINED OPEN. THE CLIPS REMAINED BLOCKED AS WELL. ANOTHER CLIP APPLIER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20047883 ↗
• MalfunctionMay 10, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE WHEN THE ISSUE OCCURRED, AND ONLY ONE CLIP CAME OUT OF THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 16902691 ↗
• InjuryMar 7, 2023Entrapment of Device; Difficult to Open or Close; Material Twisted/Bent; Entrapment of Device; Difficult to Open or Close; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE WAS LOCKED AND THE SURGEON COULD NOT REMOVE THE DEVICE FROM THE TISSUE. THE DEVICE WAS BENT TOO GET IT LOOSE. THE INCISION WAS EXTENDED DUE TO THE PRODUCT PROBLEM. A NEW INSTRUMENT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 16500322 ↗
• InjuryFeb 17, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC NEPHRECTOMY, THE CLIP APPLIER JAMMED AFTER ONE USE. THE JAWS WOULD NOT OPEN OR RELEASE A CLIP. IT WAS STATED THAT THERE WAS BLOOD LOSS WITH LESS THAN 500CC. THE CASE HAD TO BE CONVERTED TO AN OPEN PROCEDURE AND HEMOSTATIC PATCH WAS USED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16399808 ↗
• InjuryFeb 14, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC NEPHRECTOMY, THE TWO CLIP APPLIERS FROM THE SAME BATCH DID NOT CLIP AS IT SHOULD. THE DEVICES GOT STUCK. THE JAWS WOULD NOT OPEN OR RELEASE A CLIP THAT RESULTED IN A CONVERSION TO AN OPEN PROCEDURE AND USED HEMOSTATIC PATCH AS THE PATIENT HAD BLOOD LOSS WITH LESS THAN 500CC.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16373711 ↗
• InjuryFeb 14, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC NEPHRECTOMY, THE TWO CLIP APPLIERS FROM THE SAME BATCH DID NOT CLIP AS IT SHOULD. THE DEVICES GOT STUCK. THE JAWS WOULD NOT OPEN OR RELEASE A CLIP THAT RESULTED IN A CONVERSION TO AN OPEN PROCEDURE AND USED HEMOSTATIC PATCH AS THE PATIENT HAD BLOOD LOSS WITH LESS THAN 500CC.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16373611 ↗
• MalfunctionSep 29, 2022Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, AT THE START OF USE, THE DEVICE WAS DEFECTIVE FROM THE FIRST CLIP. THE SURGEON COULD NOT SQUEEZE THE HANDLE TO FIRE DUE TO THE CLIPS BEING DERAILED AFTER THE FIRST SQUEEZE. IT WAS ALSO NOTED THAT THE ERGONOMICS OF THE GRIPPER AND THE HANDLE WAS DIFFICULT TO ORIENT DUE TO THE DIRECTION WHEEL BEING TOO SMALL AND TOO FAR. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15502194 ↗
• MalfunctionSep 9, 2022Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THORACOSCOPIC LOBECTOMY, THE PHENOMENON OF STUCK STAPLE WAS FOUND, AND IT COULD NOT BE USED NORMALLY. THE JAWS OF THE DEVICE WOULD NOT CLOSE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396452 ↗
• MalfunctionAug 31, 2022Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, WHEN THE SURGEON WAS SETTING A CLIPS ON A VESSEL THE CLIPS WAS STAYING IN THE CLIP APPLIER. THE CLIP WAS STUCK IN THE CLIP APPLIER WHEN THE SURGEON PUSHED FORWARD THE CLIP. A NEW DEVICE WAS USED TO RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15329328 ↗
• MalfunctionAug 26, 2022Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PANCREATIC SURGERY, WHEN DEALING WITH THE SUPERIOR MESENTERIC VEIN, AFTER THE FIRST TITANIUM CLIP WAS CLOSED, IT WAS FOUND THAT THE CLIP WAS DEFORMED. TO RESOLVE THE ISSUE, A SINGLE-FIRE DEVICE FROM ANOTHER MANUFACTURER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15302948 ↗
• MalfunctionAug 25, 2022Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, THE CLIP APPLIER DID NOT WORK, WHEN THE USER SQUEEZED THE HANDLE NOTHING HAPPENED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15297857 ↗
• MalfunctionAug 25, 2022Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A TRANSABDOMINAL PREPERITONEAL (TAPP) PROCEDURE, THE CLIP DID NOT DETACH FROM THE PLIERS. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15294026 ↗
• InjuryAug 2, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, AT THE TIME OF PLACING CLIPS ON THE ARTERY AND CYSTIC DUCT, AFTER SEVERAL ATTEMPTS AT STAPLING, THE FORCEPS MADE A BREACH IN THE CYSTIC ARTERY CAUSING BLEEDING AND MOREOVER THE SURGEON DID NOT FEEL THAT THE CLIP PROVIDED WELL ON THE TISSUE. IT WAS ALSO STATED THAT THE ROTATION KNOB WAS VERY DIFFICULT TO ACCESS AND VERY HARD TO HANDLE. IN ADDITION, THE PLASTIC HANDLE IS VERY FRAGILE AND BROKE. THE PATIENT EXPERIENCED TEMPORARY INJURY AS A RESULT. THE SURGEON PERFORMED HEMOSTASIS TO STOP THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 15153818 ↗
• MalfunctionFeb 14, 2022Break; Break

  ACCORDING TO THE REPORTER, THE HANDLE PHYSICALLY BROKE ON THE 1ST PRESSURE WHEN LOADING THE DEVICE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524382 ↗
• MalfunctionFeb 14, 2022Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE HANDLE PHYSICALLY BROKE ON THE FIRST PRESSURE WHEN LOADING THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524178 ↗
• MalfunctionFeb 14, 2022Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE HANDLE PHYSICALLY BROKE ON THE 1ST PRESSURE WHEN LOADING THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524030 ↗
• MalfunctionFeb 13, 2022Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, PRIOR TO THE DEVICE BEING INSERTED TO THE PATIENT, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE BUT THE HANDLE PHYSICALLY BROKE ON THE 1ST PRESSURE WHEN LOADING THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13519484 ↗
• MalfunctionJan 20, 2022Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC NEPHRECTOMY, WHEN DISCONNECTING THE RENAL ARTERY, THE JAWS DID NOT CLOSE AFTER SQUEEZING THE HANDLE. THE SURGEON USED A COMPETITOR'S DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13306422 ↗
• MalfunctionJan 6, 2022Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A THORACIC SURGERY LOBECTOMY, THE SURGEON WAS NOT ABLE TO SQUEEZE THE HANDLE DURING THE HALF OF THE USE. THE STAPLES WERE STUCK. THE SURGEON REPLACED THE DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13181127 ↗
• MalfunctionJan 5, 2022Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON WAS ABLE TO SQUEEZED THE HANDLE BUT THE JAWS OF THE DEVICE DID NOT CLOSE COMPLETELY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13173140 ↗
• MalfunctionDec 22, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN THE SURGEON TRIED TO LIGATE THE BLEEDING VESSEL, AFTER INSERTING THE DEVICE INTO PATIENT CAVITY THROUGH TROCAR. THE SURGEON WAS UNABLE TO LOAD CLIP INTO THE JAW BY SQUEEZING THE LOADING TRIGGER. TRIED MULTIPLE TIMES, UNFORTUNATELY STILL UNABLE TO LOAD THE CLIP. THE SURGEON USED A NEW DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13061101 ↗
• MalfunctionDec 8, 2021Difficult to Open or Close; Mechanics Altered; Difficult to Open or Close; Mechanics Altered

  ACCORDING TO THE REPORTER DURING A PROCEDURE , THE USER WAS ABLE TO SQUEEZED THE HANDLE, BUT THE JAWS CANNOT BE CLOSE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12965537 ↗
• MalfunctionNov 29, 2021Difficult to Open or Close; Mechanics Altered; Difficult to Open or Close; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT HEPATECTOMY, THE CLIP WAS STUCK IN THE JAWS OF THE DEVICE DURING HALF OF FIRING AND THE FIRING COULD NO LONGER BE CARRIED OUT. THE JAWS WERE NOT ABLE TO CLOSE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882135 ↗
• MalfunctionAug 30, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING TO LAPAROSCOPIC RIGHT HEPATECTOMY, THE CLIP CAN BE LOADED, BUT THE JAWS OF THE CLIP APPLIER WOULD NOT PROPERLY CLOSE WHEN THE FIRING GRIP WAS BEING SQUEEZED. ANOTHER CLIP APPLIER OF THE SAME MODEL WAS OPENED TO PROCEED WITH THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12387728 ↗
• MalfunctionAug 17, 2021Mechanical Problem; Mechanics Altered; Mechanical Problem; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING ENDOSCOPIC HEPATECTOMY IN LIVER TRANSECTION SURFACE BLOOD VESSEL, THERE WAS AN ISSUE WITH LOADING OR FIRING OF THE CLIPS. SOME OF THE CLIPS WAS ALSO MALFORMED. TO RESOLVE THE ISSUE, AN EW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12333450 ↗