Lapro-Clip 8886848882Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10884521057678), received between Aug 22, 2017 and Sep 15, 2026 — classified as 3 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (20 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Mechanical Problem

  It was reported that during a laparoscopic cholecystectomy, while on bile duct, the clip wouldn't close. Another clip was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766578 ↗
• MalfunctionAug 10, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50191432 ↗
• MalfunctionJan 6, 2026Break

  ACCORDING TO THE REPORTER, DURING INTRA-ABDOMINAL LIGATION IN THE OPERATION, THE LIGATION CLIP BROKE, WHICH PROLONGED THE OPERATION TIME. THE CLIP WAS REPLACED AND THE PROCEDURE CONTINUED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981349 ↗
• MalfunctionMar 31, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE USE OF THE CLIP APPLIER, THE SECOND CLIP DID NOT FORM CORRECTLY AFTER FIRING AND CRACKED SOON. THE INNER AND OUTER PARTS OF THE CLIP SEPARATED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21735367 ↗
• MalfunctionJan 16, 2025Mechanical Problem; Device Slipped; Mechanical Problem; Device Slipped

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE INNER CLIP DID NOT CORRECTLY FORM TO LOCK THE TISSUE. THE DEVICE CLAMPED AFTER FIRING BUT SOON BECAME LOOSENED. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170253 ↗
• MalfunctionNov 29, 2024Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE SURGEON TRIED TO USE THE DEVICE, THE TWO CARTRIDGES WERE DISTORTED AND COULD NOT BE USED IT IS UNKNOWN WHETHER THE DEVICE WAS DISTORTED DURING USAGE OR BEFORE USE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20810800 ↗
• MalfunctionNov 29, 2024Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE SURGEON TRIED TO USE THE DEVICE, THE TWO CARTRIDGES WERE DISTORTED AND COULD NOT BE USED IT IS UNKNOWN WHETHER THE DEVICE WAS DISTORTED DURING USAGE OR BEFORE USE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20810759 ↗
• MalfunctionNov 14, 2024Device Slipped; Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIP WAS FIRED COMPLETELY, HOWEVER THE CLIP DID NOT CLAMP ANY TISSUE, AND THE INNER AND OUTER PARTS WERE SEPARATED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684284 ↗
• MalfunctionJul 23, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLON RESECTION, WHILE CLIPPING THE BLOOD VESSEL, THE TWO FIRED CLIPS WERE NOT FULLY CLOSED AND THE CLIPS MISFIRED, IT WAS NOT COMPLETED. ADDITIONALLY, THE CLIP'S INNER AND OUTER PARTS DISCONNECTED. TO RESOLVE THE ISSUE, ANOTHER DEVICE WITH THE SAME LOT NUMBER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805621 ↗
• MalfunctionJul 19, 2024Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, THE CLIP THAT FIRED COULD NOT BE CLOSED. ANOTHER CLIP WAS LOADED AND USED ON THE SAME HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. DEVICE RETURNED WITHOUT ACCOMPANYING INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19786000 ↗
• InjuryFeb 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: Unintended Radiation Exposure

  MAUDE report 18691287 ↗
• MalfunctionOct 3, 2023Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE UROLOGIST TRIED TO LINE THE VESSEL WITH CLIP APPLIER, THE CLIP DID NOT LINED THE VESSEL. A NEW DEVICE WAS OPEN TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865774 ↗
• MalfunctionOct 3, 2023Device Slipped; Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) HERNIOPLASTY, THE UROLOGIST TRIED TO LINE THE VENOUS VESSEL WITH CLIP APPLIER, BUT THE CLIP APPLIER DID NOT LINE THE VESSEL (CLIP DID NOT HOLD TIGHTLY TO THE VESSEL AND DETACHED). THE INNER AND OUTER PARTS OF THE CLIP SEPARATED. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865022 ↗
• InjuryJan 6, 2023Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOID COLON RESECTION, WHEN THE CLIP WAS USED BEFORE THE BLOOD VESSEL RESECTION, CLIPPING WAS POSSIBLE, BUT THE CLIP COULD NOT BE DETACHED FROM HANDLE IN THE BODY CAVITY. THE BLOOD VESSEL WAS SEALED IN COMPETITOR'S DEVICE AND THEN RESECTED AFTER CONFIRMING THAT THERE WERE NO PROBLEMS. RESECTION ALONG WITH BLOOD VESSEL THAT WAS CLAMPED BY CLIP. WHEN IT WAS TAKEN OUT FROM THE BODY, ITS GETS CAUGHT IN THE PORT AND COULD BE REMOVED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16115730 ↗
• MalfunctionOct 14, 2022Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER, DURING A CHOLECYSTECTOMY, AFTER EXPOSURE OF THE GALLBLADDER TRIANGLE, THE SURGEON NEEDED TO USE A BIOLOGICAL CLIP TO CLOSE THE CYSTIC ARTERY OR COMMON BILE DUCT. THE 8 MILLIMETERS LIGATION CLIP WAS GIVEN, THE CLOSURE WAS NOT TIGHT, AND THE BLEEDING STILL OCCURRED. IMMEDIATELY REPLACED WITH ANOTHER LIGATION CLIP, AND COMPLETED THE OPERATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611519 ↗
• MalfunctionDec 28, 2021Device Slipped; Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE CLIP WAS FIRED COMPLETELY. HOWEVER, THE CLIP DID NOT CLAMP ANY TISSUE AND THE INNER AND OUTER PARTS OF THE CLIP SEPARATED. THE SURGEON USED A NEW LOADING UNIT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13100089 ↗
• MalfunctionJun 21, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING HEMOSTASIS UPON DE-ROOFING AND DECOMPRESSION OF MULTIPLE RENAL CYSTS IN BOTH KIDNEY, THE FRONT END OF BOTH ABSORBABLE HEMOSTATIC CLIP OPENED BUT COULD NOT BE CLOSED. SURGEON REPLACED THE DEVICE BY A NEW HEMOSTATIC CLIP IMMEDIATELY. THE TREATMENT TIME WAS AFFECTED.

  Patient problems: Insufficient Information

  MAUDE report 12037649 ↗
• MalfunctionJun 1, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE OPERATOR TRIED TO LIGATE THE CYSTIC DUCT WITH THE CLIP APPLIER, BUT IT FAILED. THE PICTURE SHOWED THAT THE CLIP DID NOT CLOSE COMPLETELY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11912411 ↗
• MalfunctionFeb 4, 2021Mechanical Problem; Mechanics Altered; Mechanical Problem; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE OPERATOR USED THE CLIP TO CLAMP THE BLOOD VESSEL. THE OPERATOR TOOK OUT THE APPLIER AND FOUND OUT THAT THE CLIP DID NOT PERFORM CLOSURE AND LEFT INSIDE THE CARTRIDGE. THE FIRST CLIP WAS NOT FIRED COMPLETELY. THE SURGEON FIRED THE SECOND CLIP IN THE SAME PACKAGE WITHOUT ANY DIFFICULTY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11279029 ↗
• MalfunctionOct 12, 2020Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHILE THE SURGEON WAS TRYING TO CLIP THE BILE DUCT, THE CLIPS WERE NOT ABLE TO BE LOADED PROPERLY AND WERE NOT ABLE TO DISENGAGE FROM THE CARTRIDGE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10662234 ↗
• 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 10567435 ↗
• MalfunctionApr 6, 2020Mechanical Problem; Device Slipped; Detachment of Device or Device Component; Mechanical Problem; Device Slipped; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE SURGEON WAS TRYING TO CLIP BILE DUCT, THE CLIP WAS ABLE TO FORM CORRECTLY. THE OUTER LAYER DID NOT LOCK THE NOTCH OF THE INNER LAYER WHILE CLIPPING. THEY OPENED A NEW ONE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9927715 ↗
• MalfunctionJul 22, 2019Mechanical Problem; Difficult to Open or Close; Mechanical Problem; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PARTIAL NEPHRECTOMY, THE DEVICE DID NOT CLAMP WELL, THE CLAMPING FORCE WAS WEAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8814561 ↗
• MalfunctionMay 16, 2019Mechanical Problem; Failure to Fire; Mechanical Problem; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLEDOCHOLITHOTOMY PROCEDURE, WHEN PERFORMING CLIPPING ON THE CYSTIC DUCT, THE EXTERIOR SIDE OF THE CLIP DID NOT COME OUT, AND THE CLIP COULD NOT BE CLOSED. THERE WERE 2 CARTRIDGES PACKAGED TOGETHER, AND ONE OF THEM WAS ABLE TO BE USED AS USUAL WITH THE SAME LOT NUMBER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8618443 ↗
• MalfunctionOct 29, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, THE EVENT OCCURRED WITH THE FIRST PACKET. EVEN THOUGH THERE WAS NO PROBLEM WITH LOADING THE CARTRIDGE, WHEN FIRING THE CLIPS IN A LAPAROSCOPIC CHOLECYSTECTOMY, THE CLIPS DIDN¿T DEPLOY WELL FOR 3 TIMES CONSECUTIVELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8016291 ↗