BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP BALL ELECTRODE

    MDR report key: 18631012 · Received February 2, 2024

    Report

    Report Number
    1216677-2024-00001
    Event Type
    Malfunction
    Date Received
    February 2, 2024
    Date of Event
    January 17, 2024
    Report Date
    March 6, 2024
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    00888937010916
    PMA / PMN Number
    K905747
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE LOCATION IS UNKNOWN. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 07-AUG-2023 UNDER WORK ORDER (B)(4) AND WAS SOLD ON 16-SEP-2023. MANUFACTURING RECORD REVIEW: DHR-336585 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED NO SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT, ONE BOX OF B0512, WAS RETURNED IN SEALED POUCHES ON 25/JAN/2024 ON RMA NUMBER (B)(4). THE LOT NUMBER OF THE RETURNED PRODUCT MATCHED THE LOT NUMBER REPORTED. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT PRODUCT WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY. 5 ELECTRODES WERE RETURNED IN SEALED POUCHES. THE 5 ELECTRODES WERE CONNECTED TO A LEEP PRECISION UNIT AND ALL 5 UNITS TRANSFERRED ELECTRICITY WHEN THE GENERATOR WAS ACTIVATED. NONE OF THE UNITS THAT THE CUSTOMER HAD AN ISSUE WITH WERE RETURNED. THE LOT NUMBER IS DEPLETED FROM INVENTORY. ROOT CAUSE: ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BALL ELECTRODES WERE NOT CAUTERIZING. NO ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. 1216677-2024-00001 B0512 BALL ELECTRODES 2024-01-0000379.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1621021 LEEP BALL ELECTRODE OPEN-SURGERY ELECTROSURGICAL ELECTRODE, MONOPOLAR, SINGLE-USE HGI COOPERSURGICAL, INC. B0512 336585 00888937010916

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown