BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION

    MDR report key: 14733599 · Received June 17, 2022

    Report

    Report Number
    1216677-2022-00190
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    May 26, 2022
    Report Date
    June 17, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K963348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 0

    REPORT FORWARDED BY CSI TRUMBULL SERVICE & REPAIR. "THIS COMPLAINT IS FOR FILE ONLY. PRODUCT WILL NOT BE RETURNED, AS THERE IS NO CORRECTIVE ACTION FOR THIS. COMPLAINT: WHEN REMOVING THE DISPOSABLE PEN OR RETURN PAD, GENERATOR CAN PULL FORWARD FROM CART WHICH DISCONNECTS THE ELECTRICAL POWER FROM THE RECEPTACLE IN THE BACK OF THE HOUSING." ADDITIONAL INFORMATION PER TRUMBULL SERVICE & REPAIRS. THIS POSSIBLE DISCONNECTION OF THE PEN WOULD HAPPEN WHEN REMOVING IT FROM THE LEEP UNIT AFTER THE PROCEDURE ENDED, SO NO PATIENT HARM OR RISK. BUT WHEN PREPARING FOR THE NEXT USE, THE UNIT NOW MAY NOT TURN ON AT ALL WHICH WOULD EITHER STOP THE PROCEDURE FROM HAPPENING OR DELAY IT AS THEY TROUBLESHOOT THE UNIT. LEEP PRECISION INTG SYS LP-10-120 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813201 LEEP PRECISION LEEP PRECISION HGI COOPERSURGICAL, INC. LP-10-120 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other