Endo Clip II 176657Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,183 adverse event reports that list this exact device (DI 10884521057869), received between Jun 14, 2016 and Sep 30, 2026 — classified as 49 injuries, 1,134 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (672 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 1,183 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955024 ↗
• MalfunctionSep 30, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954931 ↗
• MalfunctionSep 30, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951269 ↗
• MalfunctionSep 29, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935551 ↗
• MalfunctionSep 28, 2026Fail-Safe Problem; Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924299 ↗
• MalfunctionSep 22, 2026Mechanical Problem; Failure to Fire

  Patient problems: Insufficient Information

  MAUDE report 50860381 ↗
• MalfunctionSep 18, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831503 ↗
• MalfunctionSep 17, 2026Misfire

  According to the reporter, the clip applier was faulty.

  Patient problems: Insufficient Information

  MAUDE report 50802882 ↗
• MalfunctionSep 17, 2026Misfire

  According to the reporter, during a procedure, while attempting to clip the gallbladder, the clip would not release from the device. It was retracting back into the device. The surgeon used the same two devices but experienced the same issue. Another company¿s device was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802726 ↗
• MalfunctionSep 15, 2026Mechanics Altered

  According to the reporter during the laparoscopic left hepatectomy, when the hepatic vein was clamped, the clip became stuck. Vascular clamping was then performed using clips from another manufacturer. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778862 ↗
• MalfunctionSep 15, 2026Mechanics Altered

  It was reported that prior to the procedure, the surgeon experienced an issue with the loading or firing of the clip, and the clips were not able to load properly into the jaws. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773787 ↗
• MalfunctionSep 15, 2026Mechanics Altered

  It was reported that, during a laparoscopic cholecystectomy, while clipping the cystic duct, there was an issue with loading or firing the clips. A new clip applier was opened to complete the procedure. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766485 ↗
• MalfunctionSep 15, 2026Mechanics Altered

  It was reported that prior to the procedure, the surgeon experienced an issue with the loading or firing of the clip, and the clips were not able to load properly into the jaws. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766481 ↗
• MalfunctionAug 31, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533217 ↗
• MalfunctionAug 30, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50510645 ↗
• MalfunctionAug 24, 2026Mechanical Problem; Material Deformation; Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50419986 ↗
• MalfunctionJul 17, 2026Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THERE WERE ISSUES EXPERIENCED WITH THE LOADING OF THE CLIPS.

  Patient problems: Insufficient Information

  MAUDE report 25861607 ↗
• MalfunctionJul 14, 2026Mechanical Problem; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25808948 ↗
• MalfunctionJun 18, 2026Mechanics Altered; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, THE CLIP APPLIER HAD A FIRING ERROR.

  Patient problems: Insufficient Information

  MAUDE report 25546410 ↗
• InjuryJun 17, 2026Detachment of Device or Device Component; Material Deformation; Material Twisted/Bent; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHILE BEING USED ON A BILE DUCT INJURY DESCRIBED AS A BILE DUCT NICK OCCURRED WITH ASSOCIATED TISSUE DAMAGE. THE CYSTIC ARTERY AND DUCT WERE DISSECTED OUT. THE SURGEON PLANNED TO CLIP AND DIVIDE THE CYSTIC ARTERY IN PREPARATION FOR CHOLANGIOGRAPHY. THE FIRST ATTEMPTED CLIPPING OF THE CYSTIC ARTERY RESULTED IN SCISSORING OF THE CLIP. SURGEON DID NOT SEE OBVIOUS DEFORMITY OF CLIP APPLIER AND TRIED TO APPLY A SECOND CLIP. WHICH RESULTED IN EVEN WORSE SCISSORING OF CLIP WHICH DID NOT OCCLUDE AND RESULTED IN ARTERIAL BLEEDING AS WELL AS IMMEDIATE DRAINING OF BILE JUST BELOW THE ARTERY. THIRD CLIP WAS LOADED WITH NO ISSUE, BUT CLIP FELL OUT OF THE JAWS. IT WAS IDENTIFIED THAT THERE WAS A FULL THICKNESS TEAR LESS THAN 1MM IN SIZE OF THE COMMON HEPATIC DUCT APPROXIMATELY 1CM ABOVE THE CYSTIC DUCT JUNCTION. ANOTHER CLIP APPLIER WAS USED TO CONTINUE. INTRAOPERATIVE CONSULTATION BY TRAINED HEPATO-PANCREATO-BILIARY (HPB) SURGEON TALKED TO COLLEAGUE IN PORTLAND AND IT WAS RECOMMENDED LEAVING A DRAIN IN PLACE AND TRANSFERRING PATIENT FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). A SECONDARY PROCEDURE WITH STENT PLACEMENT

  Patient problems: Biliary Leak; Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 25541186 ↗
• MalfunctionJun 15, 2026Mechanics Altered

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC GASTRIC BYPASS, THE SURGEON FIRED THE FIRST CLIP. ON THE SECOND ATTEMPT, THE HANDLE LEVER WAS SQUEEZED BUT WOULD NOT ¿CLICK¿. THE JAW COULD NOT BE ENGAGED. NO CLIPS WERE FIRED FROM THE CLIP APPLIER. ANOTHER CLIP APPLIER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25513761 ↗
• MalfunctionJun 5, 2026Difficult to Open or Close; Mechanics Altered

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY PRIOR TO PATIENT USE, THE JAWS OF THE CLIP APPLIER DID NOT CLOSE AND THE CLIPS DID NOT LOAD PROPERLY INTO THE JAWS. THE PHYSICIAN COMPLETED THE CASE BY USING AN ALTERNATIVE PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25403973 ↗
• MalfunctionMay 29, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHILE BEING USED TO THE CYSTIC ARTERY AND CYSTIC VEIN, WHEN THE STAPLER FIRED BUT THE HOOKS DID NOT COME OUT AND THE CLIPS REMAINED STUCK. A REUSABLE MANUAL CLIPPER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25327493 ↗
• MalfunctionMay 21, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY AND, AT THE TIME OF DISSECTION, TWO CLIPS FIRED INSTEAD OF ONE WHEN THE SURGEON SQUEEZED THE INSTRUMENT HANDLE. THE SURGEON REPLACED THE CLIP APPLIER WITH ANOTHER OF THE SAME PRODUCT TYPE TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243441 ↗
• MalfunctionApr 24, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) LUNG RESECTION PROCEDURE, THE PATIENT WHO HAD HISTORY OF A SUSTAINED A STAB WOUND THAT PENETRATED THE LUNGS AND REQUIRED AN EXPLORATORY PROCEDURE, EXPERIENCED AN ISSUE IN WHICH THE CLIPS WERE LOADED BUT WOULD NOT CLOSE. IT WAS FURTHER REPORTED THAT A VESSEL RIP/LACERATION OCCURRED WITH PROFUSE VESSEL BLEEDING, WHICH WAS ATTRIBUTED TO ONE OF THE CLIP APPLIERS. TISSUE DAMAGE WAS REPORTED AS A TEMPORARY INJURY. THE BLEEDING WAS MANAGED INTRAOPERATIVELY USING AN ENERGY DEVICE (HARMONIC) TO CONTROL THE BLEED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 24991025 ↗