BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT "HIQ+", 5 X 330 MM

    MDR report key: 16986978 · Received May 23, 2023

    Report

    Report Number
    9610773-2023-01400
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    May 1, 2023
    Report Date
    September 7, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761009843
    PMA / PMN Number
    K944200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    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

    UPDATED FIELDS: H6, H10. CORRECTED FIELDS: B5 (INADVERTENTLY MISSED), G2 (ADDED SELECTION), H10. CORRECTION TO H10: THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. 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 CONCLUSIVELY DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. FROM THE AVAILABLE INFORMATION, IT IS LIKELY THE REPORTED EVENT OCCURRED DUE TO USE ERROR OR WEAR AND TEAR. THE HALAR COATING USED FOR INSULATING THE SHAFT HAD PROBABLY HARDENED DUE TO FREQUENT USAGE AND REPROCESSING, WHICH LED TO THE INSULATION LOOSENING AT INDIVIDUAL SPOTS. THEREFORE, IT IS LIKELY THE CUSTOMER DID NOT CHECK THE TUBE SHAFT PROPERLY BEFORE USE PER THE INSTRUCTIONS FOR USE (IFU) AND USED A DAMAGED OR WORN INSTRUMENT. IT WAS ALSO NOTED THAT THE PRODUCT IS DESIGNED FOR 400X REPROCESSING CYCLES. THE EXPECTED SERVICE LIFE HAS LIKELY BEEN EXCEEDED CONSIDERING THE SHAFT¿S DATE OF MANUFACTURE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT ON MAY 2ND DURING A SURGERY, SPARKS WERE EMITTED FROM THE SHEATH WHEN HIGH-FREQUENCY OUTPUT WAS GENERATED FROM THE LAPAROSCOPIC FORCEPS (HIQ PLIUS). THE CLINICAL ENGINEER CHECKED THE CONDITION OF THE SHEATH AFTER THE SURGERY AND FOUND THAT THERE WERE PLACES WHERE THE METAL UNDER THE INSULATING COATING WAS EXPOSED. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Description of Event or Problem · 0

    THE PROCEDURE WAS A THERAPEUTIC LAPAROSCOPIC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183527 SHAFT "HIQ+", 5 X 330 MM SURG, NON-EN HET OLYMPUS WINTER & IBE GMBH A60800A 06XW-0787 04042761009843

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown