Lapro-Clip 8886848700Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10884521057623), received between Jun 20, 2018 and Sep 9, 2025 — classified as 2 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (13 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Break; Break

  IT WAS REPORTED THAT PREOPERATIVELY, DURING DEVICE FOLLOW-UP, THE CLIP APPLIER BROKE AFTER THE STERILIZATION PROCESS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009295 ↗
• MalfunctionAug 29, 2025Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE INNER AXLE OF THE APPLIER WAS BENT AND WOULD FALL FROM THE TOP. THE HANDLE WAS ALSO SHA KING. ANOTHER CLIP APPLIER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22928924 ↗
• MalfunctionApr 2, 2025Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN UNPACKING THE PRODUCT AT THE CLINIC, THE APPLICATOR WAS FOUND TO BE DEFECTIVE IN THE PACKAGING. THE DEVICE WAS PARTIALLY DISCONNECTED AND UNABLE TO BE TRIGGERED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751691 ↗
• MalfunctionFeb 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRECTOMY SURGERY, AFTER FIRING THE CLIP APPLIER, WHEN IT WAS PULLED, THE CARTRIDGE AND THE APPLIER DETACHED IN THE ABDOMINAL CAVITY AND REMAINED IN THE PATIENT'S BLOOD VESSEL WERE GRASPED WITH FORCEPS. THEN, THE CARTRIDGE AND CLIP CAME OFF, AND THE CLIP WAS USED ON THE PATIENT AS IT WAS. IT WAS NOTED THAT NOTHING HAD FALLEN OTHER THAN THE CARTRIDGE AND AN X-RAY WAS PERFORMED TO LOCATE IT. THE CARTRIDGE WAS REMOVED WITH FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18692092 ↗
• MalfunctionFeb 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRECTOMY SURGERY, AFTER FIRING THE CLIP APPLIER, WHEN IT WAS PULLED, THE CARTRIDGE AND THE APPLIER DETACHED IN THE ABDOMINAL CAVITY AND REMAINED IN THE PATIENT'S BLOOD VESSEL WERE GRASPED WITH FORCEPS. THEN, THE CARTRIDGE AND CLIP CAME OFF, AND THE CLIP WAS USED ON THE PATIENT AS IT WAS. IT WAS NOTED THAT NOTHING HAD FALLEN OTHER THAN THE CARTRIDGE AND AN X-RAY WAS PERFORMED TO LOCATE IT. THE CARTRIDGE WAS REMOVED WITH FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691490 ↗
• MalfunctionDec 20, 2023Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE DEVICE WAS BROKEN; THE INNER SHAFT WAS DIFFICULT TO BE TAKEN OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369690 ↗
• MalfunctionMay 26, 2023Entrapment of Device; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, AFTER FIRING, THE INNER PART OF THE CLIP DID NOT SEPARATE FROM THE BLACK PART AND GET STUCK TO THE CYSTIC ARTERY. ANOTHER LAPAROSCOPIC DEVICE WAS USED AND THE CLIP MANAGE TO RELEASE. THE SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES DUE TO DEVICE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17012459 ↗
• InjuryApr 14, 2023Break; Failure to Fire; Insufficient Device Problem Information; Break; Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIP WAS STUCK TO THE TISSUE IN THE BLOOD VESSELS SU PPLYING THE GALLBLADDER. A NEW CLIP APPLIER WAS PLACED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 16745668 ↗
• MalfunctionApr 14, 2023Break; Entrapment of Device; Difficult to Remove; Failure to Fire; Break; Entrapment of Device; Difficult to Remove; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PROBLEM WAS WORSE BECAUSE THE FORCEPS RELEASE THE CLIP, BUT THEN THE CLIP DID NOT RELEASE FROM THE FORCEPS BECAUSE THEY WERE BROKEN AND HAVE BEEN USED TO OFTEN. IT OCCURRED ON TWO CLIP APPLIERS. A NEW CLIP APPLIER WAS PLACED TO RESOLVE THE ISSUE.

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

  MAUDE report 16745392 ↗
• MalfunctionOct 13, 2022Break; Component or Accessory Incompatibility; Break; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PARTIAL NEPHRECTOMY, THE ASSISTANT WAS TRYING TO LOAD THE CLIP ONTO THE APPLIER BUT COULD NOT BE LOADED SMOOTHLY. VISUALLY, THE SHAFT OF THE HANDLE WAS BROKEN. TO RESOLVE THE ISSUE, A DEVICE FROM ANOTHER COMPANY WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15601193 ↗
• MalfunctionJul 27, 2022Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, DURING THE CLEANING STEP, THE HEALTHCARE PROFESSIONAL FOUND THAT THERE WAS A HOLE ON THE HANDLE AFTER TAKING OUT FROM PACKAGING, AND THE INNER SHAFT WAS TOO LOOSE TO BE USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15116918 ↗
• MalfunctionJun 14, 2022Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC THORACOSCOPIC RESECTION OF LUNG TISSUE OR LESIONS, WHEN CLOSING THE RIGHT PULMONARY VEIN, THE CLIP DID NOT POP OUT AND GOT STUCK WHEN DEVICE WAS FIRED. THE SURGEON TRIED MANY TIMES TO FULLY GRASP THE HANDLE OF THE APPLIER, BUT STILL COULD NOT TAKE IT OUT. AFTER NEARLY 2 MINUTES, THE ABSORBABLE LIGATURE CLIP WAS SUCCESSFULLY POPPED OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14689066 ↗
• MalfunctionJun 3, 2022Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHEN CLIPPING DUCT, THE CLIP DEPLOYED BUT SEEMED TO LOCK DOWN. THE APPLIER COULD NOT PULL BACK OFF THE CLIP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14598714 ↗
• MalfunctionJun 1, 2022Break; Mechanics Altered; Break; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHEN TRYING TO CLIP THE CYSTIC DUCT, THE DEVICE COULD NOT BE FIRED SMOOTHLY. WHEN THE DEVICE WAS REMOVED FROM THE CAVITY, THE APPLIER SUDDENLY SEPARATED INTO SEVERAL PARTS. ANOTHER APPLIER 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 14557958 ↗
• MalfunctionMay 12, 2022Difficult to Remove; Failure to Fire; Difficult to Remove; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC SURGERY, WHILE CLOSING THE BLOOD VESSEL, IT WAS NOTED THAT THE APPLICATOR THIMBLE WAS WORN, SO THAT THE CLIP COULD NOT BE BROUGHT OUT, MAKING IT DIFFICULT TO WITHDRAW. THE SURGEON USED A NEW APPLIER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14378093 ↗
• MalfunctionMay 11, 2022Device Difficult to Setup or Prepare; Mechanics Altered; Device Difficult to Setup or Prepare; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLON CANCER SURGERY PROCEDURE, WHILE FIRING THE CLIP APPLIER, THE FIRING PROCESS WAS NOT SMOOTH, AND THE INNER SHAFT COULD NOT BE TAKEN OUT. THE DEVICE WAS DIFFICULT TO DISASSEMBLE. ANOTHER PRODUCT 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 14361223 ↗
• MalfunctionNov 17, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER INTRAOPERATIVELY, THE DEVICE HAS A SIGNIFICANTLY POOR RELEASE AFTER FIRING AND THERE IS A RISK OF PULLING THE TISSUE.

  Patient problems: Insufficient Information

  MAUDE report 12833606 ↗
• MalfunctionSep 7, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC COLECTOMY, WHEN CLIPPING THE BLOOD VESSEL, THE CLIP COULD NOT BE RELEASED NORMALLY FROM THE JAWS SO THE CLIP WAS REMOVED FROM THE JAWS TO AVOID DAMAGING THE BLOOD VESSEL. THE SAME EVENT CONTINUED TO OCCUR DURING THE NEXT CLIPPING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12435309 ↗
• MalfunctionJun 7, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A ROBOTIC RIGHT PARTIAL NEPHRECTOMY, THE SURGEON EXPERIENCED DIFFICULTY IN GETTING THE CLIP OUT OF THE CLIP APPLIER. THE DEVICE WAS DISCONTINUED TO BE USED. ANOTHER DEVICE FROM THE SAME PACK 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 11947913 ↗
• MalfunctionApr 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO SURGERY, THE CLIP BARREL OR THE SHAFT OF THE CLIP APPLIER WAS DETACHED. THERE WAS NO PATIENT INV OLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617359 ↗
• MalfunctionJan 15, 2021Mechanics Altered

  ACCORDING TO THE REPORTER, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO GASTRIC MALIGNANT TUMORS AND UNDERWENT RADICAL GASTRECTOMY IN OPERATION ROOM 9. DURING THE PROCEDURE, AN ABSORBABLE LIGATURE CLIP AND REUSABLE SINGLE APPLIER WAS USED, AFTER THE TISSUE WAS CLAMPED AND CLOSED, IT COULD NOT BE SEPARATED FROM THE INSTRUMENT. THREE APPLIERS WERE USED CONSECUTIVELY AND NONE OF THEM DETACHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11180279 ↗
• MalfunctionSep 28, 2020Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE SURGEON WAS TRYING TO CLIP BILE DUCT, THE INNER AND OUTER PARTS OF THE CLIP SEPARATED AND THE CLIPS DID NOT CLOSE COMPLETELY. THE CLIP WAS STUCK IN THE CARTRIDGE AFTER FIRED. THE OPERATOR USED ANOTHER LIGATION CLIP PRODUCT FROM A DIFFERENT MANUFACTURER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10593558 ↗
• MalfunctionSep 22, 2020Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE CLIP GOT LOOSE ON THE HANDLE AND LOCKED TO HEPATIC VEIN. THE DEVICE COULD NOT BE REMOVED. THE USER MANAGED TO ANCHOR CLIP AGAIN TO INSTRUMENT AND GOT IT OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10567398 ↗
• MalfunctionSep 4, 2020Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SURGEON FOUND OUT THAT THERE WAS A HOLE ON THE SHAFT PART OF THE HANDLE DURING THE CLEANING STEP. IT WAS ALSO NOTED THAT THE INNER SHAFT ASSEMBLY DID NOT WORK NORMALLY AFTER BEING ASSEMBLED; THE SHAFT OF THE DEVICE WAS LOOSE. THE DEVICE WAS ALSO DIFFICULT TO ASSEMBLE AND DISASSEMBLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Information

  MAUDE report 10492934 ↗
• MalfunctionAug 5, 2020Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOID RESECTION, THE CLIPS WERE NOT PROPERLY LOADED ONTO THE HANDLE. THE CLIP APPLICATOR WAS UNABLE TO RELEASE. SOME OF THE CLIPS DID NOT CLICK WHEN RELOADING IN THE DEVICE BUT WERE LOCKED. AFTER TRYING TO CLIP 4 TO 5 TIMES, 1 CLIP BROKE WHEN RELEASED, FELL INTO THE PATIENT CAVITY AND WAS RETRIEVED WITH A CLAMP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370692 ↗