Olympus WA64320CRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04042761062442), received between Sep 29, 2021 and Mar 26, 2026 — classified as 1 injury, 15 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. 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PREPARATION FORCEPS DISTAL END WAS BROKEN. THERE WAS NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699128 ↗
• MalfunctionSep 17, 2025Break; Break

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073989 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT DURING REPROCESSING; THE JAWS INSERT BIPOLAR DEVICE WAS FOUND TO HAVE TEARING AT THE WHITE PIECE AT THE HEAD (DISTAL END) OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015229 ↗
• MalfunctionNov 30, 2023Material Deformation; Material Deformation

  THE CUSTOMER REPORTED TO OLYMPUS, THE JAWS, BIPOLAR, 5 X 330 MM, PREPARATION FORCEPS, HAD DAMAGED INSULATION. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18243819 ↗
• MalfunctionSep 19, 2023Break; Break

  THE INTENDED PROCEDURE WAS A THERAPEUTIC LAPAROSCOPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772964 ↗
• MalfunctionJul 20, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE TIP OF THE SUBJECT DEVICE WAS DAMAGED AND FELL OFF. THE SUBJECT DEVICE WAS NOT USED. THE REPORTED ISSUE WAS OBSERVED WHILE PREPARING THE SUBJECT DEVICE, PRIOR TO AN UNSPECIFIED THERAPEUTIC PROCEDURE. SINCE THE ISSUE OCCURRED AFTER STERILIZATION AND BEFORE USE, IT IS UNKNOWN WHERE AND WHEN IT FELL OFF. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17357639 ↗
• MalfunctionMay 26, 2023Break; Break

  OLYMPUS WAS INFORMED, THAT SEVEN (7) HIQ+ BIPOLAR MARYLAND GRASPERS BROKE WHILE PERFORMING TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) SURGERIES. DURING THE PAST YEAR, ALL SEVEN (7) ARE SEPARATE EVENTS. IT WAS REPORTED, ON SOME OF THE GRASPERS, SPARKING WAS OBSERVED, ON THE TIP WHEN USING WITH AN ELECTROSURGICAL GENERATOR. NO DEVICE COMPONENT OR FRAGMENT FELL INSIDE THE PATIENT. THERE WAS ONLY A 3¿5 MINUTE DELAY TO REPLACE THE DEVICE. AS THE INTENDED PROCEDURES WERE COMPLETED WITH ANOTHER LIKE MODEL GRASPER. THE DEVICE WAS INSPECTED BEFORE USE BY THE NURSE, PRIOR TO THE SURGERY. NO DEATH OR INJURY AND NO HARM OR IMPACT TO PATIENT OR OTHER WAS REPORTED TO OLYMPUS. THE FIRST EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6), THE SECOND EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6), THE THIRD EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6) (THIS REPORT), THE FOURTH EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6), THE FIFTH EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6), THE SIXTH EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6) THE SEVENTH EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6), THE SUBJECT DEVICE WAS SENT BACK TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010653 ↗
• MalfunctionMay 26, 2023Break; Break

  OLYMPUS WAS INFORMED THAT SEVEN (7) HIQ+ BIPOLAR MARYLAND GRASPERS BROKE WHILE PERFORMING TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) SURGERIES DURING THE PAST YEAR. ALL SEVEN (7) ARE SEPARATE EVENTS. IT WAS REPORTED ON SOME OF THE GRASPERS, SPARKING WAS OBSERVED ON THE TIP WHEN USING WITH AN ELECTROSURGICAL GENERATOR. NO DEVICE COMPONENT OR FRAGMENT FELL INSIDE THE PATIENT. THERE WAS ONLY A 3¿5 MINUTE DELAY TO REPLACE THE DEVICE AS THE INTENDED PROCEDURES WERE COMPLETED WITH ANOTHER LIKE MODEL GRASPER. THE DEVICE WAS INSPECTED BEFORE USE BY THE NURSE PRIOR TO THE SURGERY. NO DEATH OR INJURY AND NO HARM OR IMPACT TO PATIENT OR OTHER WAS REPORTED TO OLYMPUS. THE FIRST EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). THE SECOND EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). THE THIRD EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). THE FOURTH EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). (THIS REPORT) THE FIFTH EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). THE SIXTH EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). THE SEVENTH EVENT IS REPORTED UNDER PATIENT IDENTIFIER(B)(6). THE SUBJECT DEVICE WAS SENT BACK TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010521 ↗
• MalfunctionMay 26, 2023Break; Break

  OLYMPUS WAS INFORMED THAT SEVEN (7) HIQ+ BIPOLAR MARYLAND GRASPERS BROKE WHILE PERFORMING TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) SURGERIES DURING THE PAST YEAR. ALL SEVEN (7) ARE SEPARATE EVENTS. IT WAS REPORTED ON SOME OF THE GRASPERS, SPARKING WAS OBSERVED ON THE TIP WHEN USING WITH AN ELECTROSURGICAL GENERATOR. NO DEVICE COMPONENT OR FRAGMENT FELL INSIDE THE PATIENT. THERE WAS ONLY A 3¿5 MINUTE DELAY TO REPLACE THE DEVICE AS THE INTENDED PROCEDURES WERE COMPLETED WITH ANOTHER LIKE MODEL GRASPER. THE DEVICE WAS INSPECTED BEFORE USE BY THE NURSE PRIOR TO THE SURGERY. NO DEATH OR INJURY AND NO HARM OR IMPACT TO PATIENT OR OTHER WAS REPORTED TO OLYMPUS. THE FIRST EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). THE SECOND EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). THE THIRD EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). THE FOURTH EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). THE FIFTH EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). THE SIXTH EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6) (THIS REPORT) THE SEVENTH EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). THE SUBJECT DEVICE WAS SENT BACK TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010401 ↗
• MalfunctionMay 26, 2023Break; Break

  OLYMPUS WAS INFORMED THAT SEVEN (7) HIQ+ BIPOLAR MARYLAND GRASPERS BROKE WHILE PERFORMING TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) SURGERIES DURING THE PAST YEAR. ALL SEVEN (7) ARE SEPARATE EVENTS. IT WAS REPORTED ON SOME OF THE GRASPERS, SPARKING WAS OBSERVED ON THE TIP WHEN USING WITH AN ELECTROSURGICAL GENERATOR. NO DEVICE COMPONENT OR FRAGMENT FELL INSIDE THE PATIENT. THERE WAS ONLY A 3¿5 MINUTE DELAY TO REPLACE THE DEVICE AS THE INTENDED PROCEDURES WERE COMPLETED WITH ANOTHER LIKE MODEL GRASPER. THE DEVICE WAS INSPECTED BEFORE USE BY THE NURSE PRIOR TO THE SURGERY. NO DEATH OR INJURY AND NO HARM OR IMPACT TO PATIENT OR OTHER WAS REPORTED TO OLYMPUS. THE FIRST EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). THE SECOND EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). THE THIRD EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). THE FOURTH EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). THE FIFTH EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6) (THIS REPORT). THE SIXTH EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). THE SEVENTH EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). THE SUBJECT DEVICE WAS SENT BACK TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010113 ↗
• MalfunctionMay 17, 2023Break; Mechanical Jam; Break; Mechanical Jam

  THE CUSTOMER REPORTED TO OLYMPUS, THE JAWS WERE UNABLE TO BE FULLY CLOSED AND THE HINGE WAS BROKEN. THE ISSUE WAS FOUND DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY BILATERAL SALPINGO-OOPHORECTOMY. THE DAMAGE WAS DETECTED OUTSIDE THE PATIENT'S BODY BY THE SURGICAL NURSE BEFORE THE START OF THE PROCEDURE. THE JAW INSERT WAS NEITHER ACTIVATED NOR USED AND THE PROCEDURE WAS PERFORMED USING A SPARE DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950251 ↗
• MalfunctionMar 30, 2023Break; Break

  OLYMPUS WAS INFORMED, SEVEN HIQ+ BIPOLAR MARYLAND GRASPERS BROKE WHILE PERFORMING TOTAL LAPAROSCOPIC SURGERIES DURING THE PAST YEAR. ALL SEVEN ARE SEPARATE EVENTS. IT WAS REPORTED ON SOME OF THE GRASPERS, SPARKING WAS OBSERVED ON THE TIP WHEN USING WITH AN ELECTROSURGICAL GENERATOR. NO DEVICE COMPONENT OR FRAGMENT FELL INSIDE THE PATIENT. THERE WAS ONLY A 3¿5 MINUTE DELAY TO REPLACE THE DEVICE AS THE INTENDED PROCEDURES WERE COMPLETED WITH ANOTHER LIKE MODEL GRASPER. THE DEVICE WAS INSPECTED BEFORE USE BY THE NURSE PRIOR TO HANDING THE PROFESSOR. NO DEATH OR INJURY AND NO HARM OR IMPACT TO PATIENT OR OTHER WAS REPORTED TO OLYMPUS. IT WAS NOTED THE PROFESSOR AT THE USER FACILITY IS KNOWN TO BE ONE OF THE MOST EXPERIENCED USERS WITH THE HIQ+ BIPOLAR MARYLAND GRASPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16641132 ↗
• MalfunctionMar 1, 2023Break; Break

  IT WAS REPORTED TO OLYMPUS THAT A PROFESSOR WHO USES OLYMPUS BIPOLAR MARYLAND JAWS FOR HIS TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) SURGERIES. WITHIN ONE YEAR, 7 BIPOLAR MARYLAND HAVE BEEN BROKEN WHILE PERFORMING SURGERIES. ALL 7 INCIDENTS HAD PROCEDURE EXTENDED FOR 3-5 MINS EACH. ALL THE FORCEPS WERE BROKEN WHILE OPERATING SURGERIES SOME WERE SHOWN SPARKING ON THE TIP WHILE USING THE ELECTROSURGICAL GENERATOR. NO BROKEN PART FELL INTO THE PATIENT. THE DELAY DID NOT HAVE ANY INFLUENCE OR LED TO DETERIORATION OF THE PATIENTS' CONDITIONS. THE PROCEDURE WAS COMPLETED USING ANOTHER BIPOLAR MARYLAND INSERT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16464544 ↗
• MalfunctionFeb 28, 2023Break; Break

  IT WAS REPORTED TO OLYMPUS THAT A PROFESSOR WHO USES OLYMPUS BIPOLAR MARYLAND JAWS FOR HIS TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) SURGERIES. WITHIN ONE YEAR, 7 BIPOLAR MARYLAND HAVE BEEN BROKEN WHILE PERFORMING SURGERIES. ALL 7 INCIDENTS HAD PROCEDURE EXTENDED FOR 3-5 MINS EACH. ALL THE FORCEPS WERE BROKEN WHILE OPERATING SURGERIES SOME WERE SHOWN SPARKING ON THE TIP WHILE USING THE ELECTROSURGICAL GENERATOR. NO BROKEN PART FELL INTO THE PATIENT. THE DELAY DID NOT HAVE ANY INFLUENCE OR LED TO DETERIORATION OF THE PATIENTS' CONDITIONS. THE PROCEDURE WAS COMPLETED USING ANOTHER BIPOLAR MARYLAND INSERT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16453919 ↗
• InjuryMay 12, 2022Activation Failure; Activation Failure

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC MYOMA ENUCLEATION PROCEDURE THE JAWS INSERT DID NOT WORK IN BIPOLAR MODE WHEN COMBINED WITH THE ERBE VIO3 ELECTROSURGICAL UNIT. AFTER EXCHANGE OF THE VIO3 ELECTROSURGICAL UNIT WITH AN ERBE VIO 200D DEVICE, THE PROCEDURE COULD BE COMPLETED BUT THE PATIENT SUFFERED INCREASED BLOOD LOSS AND THE SURGERY TIME WAS PROLONGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14369374 ↗
• MalfunctionSep 29, 2021Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC LAPAROSCOPIC CHOLECYSTECTOMY THE FORCEPS SPARKED AND COULD NO LONGER BE OPENED OR CLOSED. THE FORCEPS WHERE THEN REMOVED AND IT WAS FOUND THAT THE INSULATION AT THE DISTAL END OF THE JAWS INSERT WAS BROKEN OFF. IT IS UNCLEAR WHETHER THE BROKEN FRAGMENT REMAINED INSIDE THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT AND SO FAR THERE HAS BEEN NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12546229 ↗