Olympus WA64130ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04042761030717), received between Sep 14, 2018 and May 6, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Material Twisted/Bent

  IT WAS REPORTED UPON INSPECTION, THE CLAMP OF THE JAWS WAS BENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093852 ↗
• MalfunctionAug 25, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THE JAWS EXHIBITED WORN/ LOOSE BRANCHES. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881749 ↗
• InjuryFeb 7, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED DURING A SURGICAL PROCEDURE THE GRASPING FORCEPS DID NOT CLOSE FLUSH BUT SLIGHTLY OFFSET. A PATIENT EXPERIENCED PROBLEMS AFTER A HEMICOLECTOMY AND REQUIRED ADDITIONAL SURGERY. DURING THE RE-OPERATION, SEVERAL INTESTINAL PERFORATIONS WERE FOUND. IT IS SUSPECTED THAT THIS WAS CAUSED BY THE GRASPING FORCEPS, SINCE THE DISTANCES CORRESPOND TO A "MECKEL'S DIVERTICULUM". HERE, THE INTESTINE IS EXAMINED PIECE BY PIECE AND THE GRASPING FORCEPS ARE USED TO GRASP AT CERTAIN INTERVALS. THE PATIENT ALSO DEVELOPED PERITONITIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NO INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: Bowel Perforation; Peritonitis

  MAUDE report 21333339 ↗
• InjuryFeb 7, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED DURING A SURGICAL PROCEDURE THE GRASPING FORCEPS DID NOT CLOSE FLUSH BUT SLIGHTLY OFFSET. A PATIENT EXPERIENCED PROBLEMS AFTER A HEMICOLECTOMY AND REQUIRED ADDITIONAL SURGERY. DURING THE RE-OPERATION, SEVERAL INTESTINAL PERFORATIONS WERE FOUND. IT IS SUSPECTED THAT THIS WAS CAUSED BY THE GRASPING FORCEPS, SINCE THE DISTANCES CORRESPOND TO A ¿MECKEL'S DIVERTICULUM¿. HERE, THE INTESTINE IS EXAMINED PIECE BY PIECE AND THE GRASPING FORCEPS ARE USED TO GRASP AT CERTAIN INTERVALS. THE PATIENT ALSO DEVELOPED PERITONITIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NO INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: Bowel Perforation; Peritonitis

  MAUDE report 21333336 ↗
• MalfunctionAug 24, 2023Break; Break

  THE CUSTOMER REPORTED THAT ON MAY 28TH, DURING REPROCESSING AFTER USE IN AN UNSPECIFIED PROCEDURE, IT WAS FOUND THAT THE TIP PROTECTIVE RUBBER OF THE INNER CORE OF THE FORCEPS WAS FOUND TO BE DETERIORATED WITH CRACKS AND EASILY DISLODGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17618498 ↗
• MalfunctionJun 7, 2022Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC LAPAROSCOPIC LIVER RESECTION PROCEDURE ONE JAW AT THE DISTAL END OF THE JAWS INSERT BROKE OFF AND FELL INTO THE PATIENT. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14617915 ↗
• MalfunctionSep 14, 2018Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC LAPAROSCOPIC SUBTOTAL GASTRECTOMY IN COMBINATION WITH A (ROUX-EN-Y) GASTRIC BYPASS (RYGB) PROCEDURE, ONE JAW GOT DETACHED FROM THE JAWS INSERT AND FELL INSIDE THE PATIENT'S BODY CAVITY. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7876319 ↗