Olympus WA64150ARecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04042761068970), received between Jul 13, 2020 and Apr 20, 2026 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Mechanical Problem

  IT WAS REPORTED THE REUSABLE RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS HAD A MALFUNCTION ON THE GRASPING FORCEPS (FORCEPS WERE CHIPPED). THE ISSUE OCCURRED DURING AN UNSPECIFIED LAPAROSCOPIC PROCEDURE. THE PROCEDURE WAS DELAYED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927324 ↗
• MalfunctionAug 25, 2025Failure to Conduct; Failure to Conduct

  IT WAS REPORTED THE JAWS EXHIBITED NO PROXIMAL INSULATION. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881748 ↗
• InjuryJul 17, 2024Break; Break

  IT WAS REPORTED, DURING THE TRANSABDOMINAL PREPERITONEAL (TAPP) CASE, THE CROCE GRASPING FORCEPS COULD NOT BE OPENED OR CLOSED NORMALLY. THE METAL CONNECTION PART FOR STRENGTHENING THE OPENING AND CLOSING HAS COME OFF AND WAS SUSPECTED TO HAVE FALLEN OFF. WHEN THE NET USED IN THE TAPP PROCEDURE WAS GRASPED FROM THE MINEYAMA TROCAR, IT MADE A NOISE AND BROKE. THE FALLEN PIECES HAVE NOT BEEN RECOVERED. THE PATIENT WAS EXAMINED WITH A COMPUTED TOMOGRAPHY (CT) SCAN AND A METAL PIECE LESS THAN 2MM IN SIZE WAS FOUND, HOWEVER IT IS UNKNOWN IF THE METAL PIECE WAS A PART OF THE BROKEN DEVICE. ABDOMINAL LAVAGE HAS BEEN PERFORMED. THE UNIT WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19760295 ↗
• MalfunctionJul 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THE RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS COULD NOT BE OPENED OR CLOSED NORMALLY. THE METAL CONNECTION PART, FOR STRENGTHENING THE OPENING AND CLOSING CAME OFF. THE ISSUE OCCURRED, DURING A THERAPEUTIC APPENDECTOMY. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19740568 ↗
• MalfunctionMay 8, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE JAWS GRASPING CROCHE FORCEPS EXHIBITED A BREAK AT THE DISTAL END WHILE BEING USED ON A PATIENT UNDERGOING AN ESOPHAGEAL PROCEDURE. THE DOCTOR SENSED SOMETHING UNUSUAL, MENTIONING THAT HE HEARD A POPPING SOUND, AND PROMPTLY WITHDREW THE FORCEPS, ONLY TO FIND THE TIP DANGLING. UPON REMOVING THE SHEATH TO INSPECT THE INSTRUMENT, THEY DISCOVERED THAT ONE SIDE OF THE HINGE AT THE BASE OF THE OPENING AND CLOSING PART HAD BROKEN OFF, WITH A PIECE ABOUT 5 MM IN SIZE MISSING. FOLLOWING THIS DISCOVERY, THE OPERATING ROOM NURSE AND DOCTOR COLLABORATED TO THOROUGHLY CLEAN THE AREA AND THEN CHECKED FOR THE MISSING PART USING AN X-RAY. ADDITIONALLY, A CT SCAN WAS CONDUCTED AFTER THE SURGERY, BUT NO FOREIGN OBJECT WAS DETECTED. THE ISSUE WAS FOUND DURING A THERAPEUTIC ESOPHAGEAL PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274909 ↗
• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED, THAT THE JAWS "HIQ+", 5 X 330 MM, GRASPING FORCEPS, CROCEOLMI METAL WAS BROKEN AT THE BASE AND THE FORCEPS AT THE TIP WOULD NOT OPEN. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNKNOWN PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18962369 ↗
• MalfunctionOct 19, 2023Break; Break

  THE CUSTOMER REPORTED THAT DURING ROBOT-ASSISTED COLECTOMY, THE JAWS UNHINGED WHEN GRASPING A LARGE PIECE OF GAUZE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. REPORTS OF THE SUBJECT DEVICE UNHINGED WHEN GRASPING A LARGE PIECE OF GAUZE AND POSSIBILITY THAT PARTS MAY HAVE FALLEN OUT OF THE PATIENT'S BODY. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE PATIENT'S ABDOMINAL CAVITY WAS WASHED MORE CAREFULLY THAN USUAL. XRAY WAS DONE AND DID NOT SHOW ANYTHING RESEMBLING ANYTHING. THERE WERE NO REPORTS OF PATIENT INJURY/ADVERSE EVENTS. THERE IS NO EVIDENCE THAT A LIFE-THREATENING EVENT OCCURRED, THAT THE PATIENT DEVELOPED PERMANENT DAMAGE OR IMPAIRMENT, AND THAT ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS DONE TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT. THERE WERE NO REPORTS OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17969764 ↗
• MalfunctionJul 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC, LAPAROSCOPIC COLECTOMY PROCEDURE, THE ROOT PORTION OF THE GRIP IS DEFORMED AND DETACHED FROM THE JAWS 5 X 330 MM, GRASPING FORCEPS. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17409644 ↗
• MalfunctionJun 22, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE BASE OF THE OPENING AND CLOSING PART OF THE GRASPING FORCEPS WAS DAMAGED. THE ISSUE WAS FOUND DURING A THERAPEUTIC LAPAROSCOPIC PROCEDURE. THE PHYSICIAN SWITCHED TO ANOTHER GRASPING FORCEPS AND THE SAME THING HAPPENED. THE PROCEDURE WAS COMPLETED WITH A THIRD SET OF GRASPING FORCEPS. THERE WERE NO REPORTS OF PATIENT HARM. THIS EVENT IS RELATED TO TWO DEVICE MALFUNCTIONS. THIS REPORT IS BEING SUBMITTED FOR THE FIRST OCCURRENCE. THE SECOND DEVICE IS BEING REPORTED ON MEDWATCH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17178683 ↗
• MalfunctionJun 21, 2023Break; Break

  THE ADDITIONAL PATIENT IDENTIFIER IS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17178278 ↗
• InjuryMay 11, 2023Material Separation; Material Separation

  A USER FACILITY REPORTED TO OLYMPUS THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE USING THE JAWS "HIQ+", 5 X 330 MM, GRASPING FORCEPS, CROCEOLMI, IT BECAME IMPOSSIBLE TO GRASP. "ABNORMAL NOISE" WAS REPORTED. THE SHAFT OF THE UNIT SEPARATED FROM THE MOVING PART OF THE JAW, AND DID NOT INTERLOCK WITH THE HANDLE OPERATION. IT WAS STATED THAT "FRACTURE SURFACE" WAS NOT VISIBLE AND DEFORMATION OF THE COMBINED SHEATHS WAS CONFIRMED. THE PROCEDURE WAS COMPLETED BY REPLACING THE EQUIPMENT WITH SIMILAR EQUIPMENT. IT WAS ALSO STATED THAT THE AT THE TIME OF THE REPORT, THE HOSPITAL COULD NOT CONFIRM THE PARTS HAD NOT BEEN RETAINED IN THE PATIENT, AND IT WAS BEING TREATED AS IF THE DEVICES HAD FALLEN INTO A BODY CAVITY. ADDITIONAL INFORMATION WAS REQUESTED MULTIPLE TIMES, BUT WAS NOT RECEIVED. THIS EVENT INVOLVED 3 DEVICES. PATIENT IDENTIFIER (B)(6) IS FOR THE JAWS "HIQ+", 5 X 330 MM, GRASPING FORCEPS, CROCEOLMI. PATIENT IDENTIFIER (B)(6) IS FOR THE SHAFT "HIQ+", 5 X 330 MM. PATIENT IDENTIFIER (B)(6) IS FOR THE HANDLE "HIQ+", ERGO S, UNIPOLAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911524 ↗
• MalfunctionMar 29, 2023Break; Break

  OLYMPUS WAS INFORMED, DURING A THERAPEUTIC LAPAROSCOPIC COLECTOMY OF THE RIGHT HEMI COLON, THE CUSTOMER HIQ+ CROCEOLMI GRASPING FORCEPS BROKE, ¿THE BASE OF THE GRASPING PART WAS DAMAGED IN THE ABDOMINAL CAVITY WHILE THE DOCTOR WAS USING THE CASE¿. IT WAS REPORTED THE DOCTOR DID NOT FORCEFULLY LIFT HEAVY ORGANS, ETC. AND THE FORCEPS WERE DAMAGED THE MOMENT FORCE WAS APPLIED TO GRASP. THE STAFF CHECKED THE PERITONEAL CAVITY, BUT NO DEVICE FRAGMENT FELL OFF, AND NO COMPONENTS WERE MISSING FROM THE GRASPER. THE PROCEDURE WAS COMPLETED WITH OTHER FORCEPS WITHOUT ANY PROBLEMS. THE DEVICE WAS INSPECTED PRIOR TO PROCEDURE AND NO ABNORMALITIES WERE NOTED. NO DEATH, INJURY OR IMPACT TO PATIENT WAS REPORTED TO OLYMPUS. NO DEVICE WILL BE RETURNED FROM CUSTOMER AND THE LOT NUMBER IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16638531 ↗
• MalfunctionMar 15, 2023Break; Break

  THE OLYMPUS FIELD SERVICE ENGINEER REPORTED THE TIE ROD AT THE DISTAL END OF THE CUSTOMER CROCEOLMI GRASPING FORCEPS HIQ JAWS ARE BROKEN. THE CUSTOMER REPORTED EVENT WAS FOUND AT INSPECTION BEFORE USE. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED TO OLYMPUS. THE DEVICE IS CLEANED DISINFECTED AND STERILIZED (CDS) WITH MANUAL CLEAN WITH ENZYME WASH AND HIGH TEMPERATURE AUTOCLAVE STERILIZATION. THE CUSTOMER THINKS THE PROBLEM WAS DUE TO CDS BUT CANNOT CONFIRM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16550525 ↗
• MalfunctionMar 15, 2023Break; Break

  IT WAS REPORTED TO OLYMPUS THAT A JAWS DISTAL END WAS BROKEN. THE PROBLEM OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16547740 ↗
• MalfunctionJan 26, 2023Break; Break

  IT WAS REPORTED TO OLYMPUS THAT THE JAWS ON THE FORCEPS WERE NOT RESPONSIVE AT ALL. THE ISSUE OCCURRED AFTER THREE USES DURING A CHOLECYSTECTOMY PROCEDURE. IT WAS REPORTED THAT THE BROKEN AREA IS BETWEEN THE JAWS WHICH MEANS IT¿S COMPLETELY LOOSE AND NOT REACTIVE. PROCEDURE FINISHED WITH REPLACEMENT OF THE DEVICE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16248577 ↗
• MalfunctionJan 26, 2023Break; Break

  IT WAS REPORTED TO OLYMPUS THAT THE JAWS ON THE FORCEPS WERE NOT RESPONSIVE AT ALL. THE ISSUE OCCURRED AFTER ONE USE DURING A HERNIA PROCEDURE. IT WAS REPORTED THAT THE BROKEN AREA IS BETWEEN THE JAWS WHICH MEANS IT¿S COMPLETELY LOOSE AND NOT REACTIVE. PROCEDURE FINISHED WITH REPLACEMENT OF THE DEVICE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247747 ↗
• MalfunctionJan 25, 2023Mechanical Problem; Mechanical Problem

  OLYMPUS (OEKG) WAS INFORMED BY THE HEAD NURSE AT THE USER FACILITY THAT THE CUSTOMER HIQ+ CROCEOLMI GRASPING FORCEPS ¿JAWS AREN¿T RESPONSIVE AT ALL.¿ THE CUSTOMER REPORTED PROBLEM OCCURRED DURING A CHOLECYSTECTOMY. THE BROKEN AREA IS BETWEEN THE JAWS AND IT IS COMPLETELY LOOSE. THERE WAS ONLY A COUPLE OF MINUTES DELAY, AND THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE. NO DEATH OR INJURY AND NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16238970 ↗
• MalfunctionJan 25, 2023Mechanical Problem; Mechanical Problem

  OLYMPUS (OEKG) WAS INFORMED BY THE HEAD NURSE AT THE USER FACILITY THAT THE CUSTOMER HIQ+ CROCEOLMI GRASPING FORCEPS ¿JAWS AREN¿T RESPONSIVE AT ALL.¿ THE CUSTOMER REPORTED PROBLEM OCCURRED DURING A CHOLECYSTECTOMY. THE BROKEN AREA IS BETWEEN THE JAWS AND IT IS COMPLETELY LOOSE. THERE WAS ONLY A COUPLE OF MINUTES DELAY, AND THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE. NO DEATH OR INJURY AND NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16238918 ↗
• MalfunctionMar 25, 2022Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OYMPUS WAS INFORMED THAT DURING A THERAPEUTIC LAPAROSCOPIC DISTAL PANCREATECTOMY PROCEDURE ONE OF THE JAWS AT THE DISTAL END OF THE GRASPING FORCEPS BROKE OFF AND FELL INTO THE PATIENT. HOWEVER, THE FRAGMENT WAS RETRIEVED IMMEDIATELY. THE INTENDED PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY. HOWEVER, A CT PROCEDURE PERFORMED SEVERAL DAYS AFTER THE ORIGINAL PROCEDURE SEEMS TO SHOW A MINUTE METALLIC FRAGMENT. IT IS UNCLEAR WHETHER THIS MAY STEM FROM THE BROKEN OFF JAWS OF THE GRASPING FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13898522 ↗
• MalfunctionJan 14, 2022Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE THE JAWS AT THE DISTAL END OF THE GRASPING FORCEPS BROKE AND A FRAGMENT FELL INTO THE PATIENT. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13257409 ↗
• MalfunctionJul 13, 2020Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE THE DISTAL END OF THE GRASPING FORCEPS APPARENTLY BROKE. IT IS UNKNOWN WHETHER A FRAGMENT BROKE OFF AND POSSIBLY FELL INTO THE PATIENT. HOWEVER, A CT AND X-RAYS CARRIED OUT BY THE CUSTOMER CONFIRMED THAT NO PARTS REMAINED INSIDE THE PATIENT'S BODY. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10262778 ↗