BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16547740 · Received March 15, 2023

    Report

    Report Number
    9610773-2023-00761
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 14, 2023
    Report Date
    April 26, 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 DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, THE ROOT CAUSE OF THE REPORTED DEFECT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE CUSTOMER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. ADDITIONAL PMA/510(K): K944201.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. 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

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915319 JAWS "HIQ+", 5 X 330 MM, GRASPING FORCEPS, CROCEOLMI LAPAROSCOPE HET OLYMPUS WINTER & IBE GMBH WA64150A 21704 04042761068970

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown