ReNew 3252Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00811099010074), received between Feb 22, 2019 and Jan 17, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2025Fracture; Fracture

  GRASPER PIECE WAS ATTACHED TO HANDPIECE AND INSERTED INTO PATIENT. WHEN SURGEON ACTIVATED GRASPER TO OPEN, THE GRASPER BROKE AND A PIECE OF GRASPER FELL INTO THE PATIENT. SURGICAL/ANESTHESIA TIME WAS EXTENDED BY FIVE MINUTES AND AN X-RAY WAS DONE TO ENSURE ALL FOREIGN MATERIAL WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21178645 ↗
• MalfunctionDec 26, 2024Break; Break

  ON (B)(6) 2024, DURING THE PREPARATION OF THE SURGICAL INTERVENTION IN THE OPERATION ROOM OF THE FINAL CUSTOMER "(B)(6) HOSPITAL " OF THE MATERIAL "RENEW LAPCLINCH GRASPER TP DISPOSABLE, REFERENCE 3252-01, OF THE BATCH 00171558" IT IS SEEN THAT ONCE OPENED, ONE LEG OF THE TIP IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019136 ↗
• MalfunctionOct 4, 2024Fracture; Fracture

  DURING A LAP CHOLECYSTECTOMY ONE OF THE GRASPER TIPS BROKE WHILE INSIDE THE PATIENT, THE TIP WAS REPLACED, AND THEY FOUND THE METAL PIECE THAT BROKE OFF IN THE PATIENT AND REMOVED IT. INSPECTION OF THE TIP TO ENSURE THAT ALL PIECES WERE ACCOUNTED FOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371113 ↗
• MalfunctionOct 1, 2024Fracture; Fracture

  JAW BROKE OFF AND FELL INTO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20348039 ↗
• MalfunctionFeb 2, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  WHEN DR. (B)(6) WAS UTILIZING THE DISPOSABLE LAPCINCH GRASPER TIP DURING A LAPAROSCOPIC CASE, PART OF THE GRASPER CAME LOOSE; HOWEVER, IT DID NOT SEPARATE. DR. (B)(6) WAS ABLE TO REMOVE THE GRASPER INTACT WITH NO HARM TO PATIENT. THE REST OF THE LOT WAS REMOVED FROM SERVICE IN AN EFFORT TO PREVENT THIS FROM HAPPENING AGAIN. FWBH SURGICAL BUYERS WERE NOTIFIED. WAS SUBMITTED INTO THE FDA - 5200630000-2022-8007.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16285803 ↗
• MalfunctionDec 14, 2022Break; Break

  APGAR DENMARK REPORTS BROKEN TIP. LOOKS LIKE 3252 FROM THE PHOTO. THE TIP BROKE INSIDE THE PATIENT IN SEVERAL PIECES, AND THEY WERE NOT SURE IF ALL THE PIECES WERE RECOVERED. MICROLINE PLANS TO EXAMINE THE TIP TO DETERMINE IF ANY FRAGMENTS REMAINED IN THE PATIENT; INITIAL INSPECTION OF THE PHOTOGRAPH OF THE DEVICE SUGGESTS THAT ALL PIECES WERE RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 15977736 ↗
• MalfunctionOct 5, 2021Fracture; Fracture

  IT WAS REPORTED THAT ITEM NUMBER 3252, LAP CLINCH, WAS BEING USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. WHEN THE SURGEON WENT TO CLAMP DOWN ON THE PATIENT'S GALL BLADDER, THE LAP CLINCH TIP POPPED, AND IT WAS OBSERVED THAT A PORTION OF THE HINGE OF THE GRASPER BROKE OFF AND FELL INTO THE PATIENT ABDOMEN. IT WAS REPORTED THAT THE STRAY PORTION WAS RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12578149 ↗
• MalfunctionFeb 27, 2020Fracture; Fracture

  A PIECE OF THE TIP BROKE OFF DURING SURGERY. ANESTHESIA TIME WAS EXTENDED FOR 30 MINUTES WHILE THE PIECE WAS RETRIEVED. A POST OPERATIVE X-RAY WAS PERFORMED TO ENSURE NO PIECE WAS LEFT IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9765469 ↗
• MalfunctionFeb 22, 2019Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn

  A PIECE OF THE TIP BROKE DURING A PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8363441 ↗