Lapro-Clip 8886848812Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10884521057654), received between Oct 23, 2017 and Apr 3, 2026 — classified as 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (15 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, AT THE CYSTIC DUCT LIGATION STEP, THE TAIL PART OF THE ABSORBABLE EXTERNAL CLIP FRACTURED. THE PRODUCT WAS REPLACED WITH A NON-ABSORBABLE LIGATING CLIP 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 24783359 ↗
• MalfunctionApr 11, 2024Break; Break

  ACCORDING TO THE REPORTER, IN A PROCEDURE FOR GALLSTONES WITH CHOLECYSTITIS, THE INSIDE OF THE ABSORBABLE LIGATION CLIP SUDDENLY BRO KE. THE INNER LAYER BROKE. THE CLIP COULD NOT LIGATE AND CLOSE. THE DEVICE USE WAS STOPPED IMMEDIATELY. A NEW ABSORBABLE LIGATION CLIP OF THE SAME MODEL AND LOT NUMBER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093964 ↗
• MalfunctionFeb 5, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL GASTRECTOMY, PRIOR TO PATIENT USE, AFTER OPENING THE PACK OF SIX CLIP APPLIERS, IT WAS FOUND THAT ALL SIX CLIPS HAD BEEN CLOSED, OR DEFORMED AND FELL OFF, MAKING IT IMPOSSIBLE TO TRY THEM OUT. 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 18647745 ↗
• MalfunctionFeb 5, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL GASTRECTOMY, PRIOR TO PATIENT USE, AFTER OPENING THE PACK OF SIX CLIP APPLIERS, IT WAS FOUND THAT ALL SIX CLIPS HAD BEEN CLOSED, OR DEFORMED AND FELL OFF, MAKING IT IMPOSSIBLE TO TRY THEM OUT. 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 18647743 ↗
• MalfunctionFeb 5, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL GASTRECTOMY, PRIOR TO PATIENT USE, AFTER OPENING THE PACK OF SIX CLIP APPLIERS, IT WAS FOUND THAT ALL SIX CLIPS HAD BEEN CLOSED, OR DEFORMED AND FELL OFF, MAKING IT IMPOSSIBLE TO TRY THEM OUT. 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 18647742 ↗
• MalfunctionFeb 5, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL GASTRECTOMY, PRIOR TO PATIENT USE, AFTER OPENING THE PACK OF SIX CLIP APPLIERS, IT WAS FOUND THAT ALL SIX CLIPS HAD BEEN CLOSED, OR DEFORMED AND FELL OFF, MAKING IT IMPOSSIBLE TO TRY THEM OUT. 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 18647718 ↗
• MalfunctionFeb 5, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL GASTRECTOMY, PRIOR TO PATIENT USE, AFTER OPENING THE PACK OF SIX CLIP APPLIERS, IT WAS FOUND THAT ALL SIX CLIPS HAD BEEN CLOSED, OR DEFORMED AND FELL OFF, MAKING IT IMPOSSIBLE TO TRY THEM OUT. 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 18647715 ↗
• MalfunctionFeb 5, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL GASTRECTOMY, PRIOR TO PATIENT USE, AFTER OPENING THE PACK OF SIX CLIP APPLIERS, IT WAS FOUND THAT ALL SIX CLIPS HAD BEEN CLOSED, OR DEFORMED AND FELL OFF, MAKING IT IMPOSSIBLE TO TRY THEM OUT. 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 18647712 ↗
• MalfunctionJan 29, 2024Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN ABDOMINAL PROCEDURE, WHEN THE CLIP APPLIERS WERE PULLED BACK, THE CLIPS DID NOT COME LOOSE. THE CLIP AND CLIP APPLIER WERE STILL CONNECTED. IN THE END, IT WAS POSSIBLE TO RELEASE THE CLIP, BUT IT WAS DIFFICULT. THE OPERATING TIME WAS SIMPLY EXTENDED. ANOTHER CLIP APPLIER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18598656 ↗
• MalfunctionDec 1, 2023Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  UPON REVIEW OF THE INFORMATION PROVIDED, THIS INFORMATION DOES NOT MEET THE DEFINITION OF A COMPLAINT. THERE IS NO WRITTEN, ELECTRONIC, OR ORAL COMMUNICATION THAT ALLEGES DEFICIENCIES RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF A DEVICE, AFTER IT IS RELEASED FOR DISTRIBUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18247928 ↗
• MalfunctionMar 22, 2023Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN USING ABSORBABLE LIGATION CLIPS FOR CLAMPING VESSELS, THERE WAS AN INCOMPLETE CLOSING. THE DEVICE WAS REPLACED WITH ANOTHER ONE, BUT IT WAS FOUND THAT THE OTHER ABSORBABLE CLIP IN THE PACKAGE IS IN FIRING STATE AND WAS NOT USED. REPLACED WITH A NEW ABSORBABLE LIGATION CLIP TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592183 ↗
• 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 14598749 ↗
• MalfunctionFeb 8, 2022Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING CLIPPING OF VESSELS IN A ROBOTIC LAPAROSCOPIC PROCTECTOMY, CLIP MISFIRED, AND CLOSED INTO AN ODD SHAPE AND DID NOT CLIP ONTO THE TISSUE. THE SURGEON OPENED ANOTHER CLIP APPLIER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480009 ↗
• MalfunctionDec 6, 2021Device Slipped; Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE FIRST CLIP DID NOT HOLD. THE DEVICE WAS THEN REMOVED FROM THE PATIENT'S ABDOMEN. THE SURGEON THEN WANTED TO APPLY A SECOND CLIP, BUT A PIECE GOT OFF-CENTER WITHOUT DETACHING FROM THE REST OF THE DEVICE AND THE POSITION WAS ABNORMAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12937020 ↗
• MalfunctionSep 22, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE CLIPS WERE NOT ABLE TO FORM CORRECTLY, THE CLIPS BITES STRANGELY. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 12513499 ↗
• MalfunctionJul 21, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHEN REMOVING THE OUTER COVERING, AFTER USING THE ABSORBABLE LIGATION CLIP FOR THE PATIENT, THE NURSE FOUND THAT THE OUTER COVERING OF THE ABSORBABLE LIGATION CLIP WAS BROKEN AND MISSING A COMPONENT. THE NURSE ON DUTY IMMEDIATELY CHECKED AND FOUND THAT THE BROKEN COMPONENT FELL INTO THE PATIENT¿S ABDOMINAL CAVITY AND REMOVED IT IN TIME WITH THE AID OF AN ENDOSCOPY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12206539 ↗
• MalfunctionJul 19, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CLIPPING WAS COMPLETED BUT THE CLIPS NEVER DIVIDED OUTER <(>&<)> INNER PART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12189852 ↗
• MalfunctionJul 8, 2021Mechanical Problem; Device Difficult to Setup or Prepare; Mechanics Altered; Mechanical Problem; Device Difficult to Setup or Prepare; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHILE CLIPPING THE CYSTIC ARTERY, THE CLIP DID NOT DETACH FROM THE CLIP APPLIER AND REMAINED STUCK IN THE DEVICE. THE DEVICE WAS ALSO DIFFICULT TO DISASSEMBLE, THE CLIP CARTRIDGE WAS UNABLE TO BE PROPERLY LOADED ONTO THE HANDLE, AND THE CLIP DID NOT FORM CORRECTLY. ANOTHER RELOAD WAS OPENED TO COMPLETE THE CASE. THE SURGICAL TIME EXTENDED FOR 3 MINUTES, BUT THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12134811 ↗
• MalfunctionJun 15, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SIGMOIDECTOMY, THE OUTSIDE CLIP WAS NOT REMOVE FROM THE INSTRUMENT. THE SURGEON THEN USE A NEW CLIP TO CLOSE THE TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12001476 ↗
• MalfunctionMay 11, 2021Mechanical Problem; Human-Device Interface Problem; Mechanical Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A ROBOTIC RADICAL PROSTATECTOMY PROCEDURE, THERE WERE ISSUES WITH THE CLIP OR CLIP CARTRIDGE. THE CLIP DID NOT FORM CORRECTLY AND THE CLIP WAS NOT ABLE TO DISENGAGED FROM THE CARTRIDGE. THE CARTRIDGE WAS DIFFICULT TO UNLOAD FROM THE HANDLE. USED ANOTHER PRODUCT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807687 ↗
• MalfunctionApr 26, 2021Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING DEPOSITION OF VENA CAVA IN A LAPAROSCOPIC ADRENALECTOMY, THE CLIP COULD BE PLACED, BUT THE CLIP DID NOT CAME OFF THE BLACK HOLDER, SO THAT THE CLIP AND BLACK HOLDER HUNG ON THE VENA CAVA. SURGEON USED TITANIUM CLIPS TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11723575 ↗
• MalfunctionApr 21, 2020Component Missing; Component Missing

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHILE TRIGGERING THE CLIP ON THE VESSEL, IT WAS NOTED THAT THERE WAS NO CLIP ON THE LOADING UNIT. ANOTHER LOADING UNIT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9984432 ↗
• MalfunctionFeb 19, 2018Mechanical Problem; Device Slipped; Mechanical Problem; Device Slipped

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHILE CLIPPING THE CYSTIC DUCT, THE DEVICE¿S CLIP DID NOT HOLD TIGHT, WHEREIN THE CLIPS WERE TOO SOFT. THE CLIPS WERE ABLE TO DISENGAGE FROM THE CARTRIDGE. AND THE CLIP CARTRIDGE WAS ABLE TO BE PROPERLY LOADED ONTO THE HANDLE. THE CLIPS WERE NOT ABLE TO FORM CORRECTLY. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7280783 ↗
• InjuryFeb 14, 2018Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO DAYS AFTER A LAPAROSCOPIC CHOLECYSTECTOMY, THE CLIPS DISSOLVED AND THE PATIENT HAD INCURRED A MASSIVE BILE IN THE ABDOMEN. THERE WAS ALSO TISSUE DAMAGE - "CYSTICUS", TISSUE LOSS, THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES. THEY HAD TO PERFORM A SECOND OPERATION WITH ANOTHER CLIP TO RESOLVE THE ISSUE. THE PATIENT WAS REPORTED WITH TEMPORARY INJURY.

  Patient problems: Injury; No Code Available; Tissue Damage

  MAUDE report 7270962 ↗
• InjuryFeb 13, 2018Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO DAYS AFTER A LAPAROSCOPIC CHOLECYSTECTOMY, THE CLIPS DISSOLVED AND THE PATIENT HAD INCURRED A MASSIVE BILE IN THE ABDOMEN. THERE WAS ALSO TISSUE DAMAGE CALLED "CYSTICUS", TISSUE LOSS, THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES. THE PATIENT HAS A TEMPORARY INJURY.

  Patient problems: Injury; No Code Available; Tissue Damage

  MAUDE report 7266669 ↗