BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAWS "HIQ+", 5 X 330 MM, GRASPING FORCEPS, CROCEOLMI

    MDR report key: 16550525 · Received March 15, 2023

    Report

    Report Number
    9610773-2023-00769
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 14, 2023
    Report Date
    April 27, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761068970
    PMA / PMN Number
    K944200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO THE OLYMPUS FOR EVALUATION AND THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. THE HOOK ON THE PULL ROD WAS DEFORMED/STRETCHED AND FRACTURED. THE DEVICE HAS NOT BEEN REPAIRED IN THE LAST YEAR. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, THE CAUSE CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE END-USER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. ADDITIONAL 510(K): K944201.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: H6, H10 CORRECTED FIELDS: H4 (CHANGED FROM NOV 1, 2020 TO NOV 22, 2021) THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED. IT IS LIKELY THE EVENT OCCURRED DUE TO IMPROPER HANDLING. THE PULL ROD AT THE DISTAL END WAS BROKEN AND THE PULL WIRE WAS HEAVILY BENT, THIS KIND OF FRACTURE INDICATES THE DEVICE WAS SUBJECTED TO A MASSIVE FORCE, WHICH CAN ONLY OCCUR IF THE JAWS ARE OPENED WIDE. AS SUCH, IT IS UNLIKELY THAT THE BREAKAGE AND BENDING OCCURRED DURING USE BUT LIKELY THE DEVICE WAS DROPPED/FELL ON A HARD SURFACE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756767 JAWS "HIQ+", 5 X 330 MM, GRASPING FORCEPS, CROCEOLMI GRASPING FORCEP HET OLYMPUS WINTER & IBE GMBH WA64150A 20Y02 04042761068970

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown