BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP SYSTEM 1000 ESU GEN. 110V

    MDR report key: 4956067 · Received July 29, 2015

    Report

    Report Number
    1216677-2015-00026
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    February 21, 2014
    Report Date
    May 19, 2015
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPAIR LOG NUMBER: (B)(4). COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT HAS BEEN RETURNED BY THE CUSTOMER FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. REFERENCE E-COMPLAINT: (B)(4).

    Description of Event or Problem · 1

    COOPERSURGICAL, INC. REPAIR LOG NUMBER (B)(4). A RETROSPECTIVE REVIEW OF THE REPORTED COMPLAINT CONDITION: "PEDAL NOT WORKING" INDICATES A PRODUCT MALFUNCTION WHICH COULD POSSIBLY NECESSITATE INTERVENTION. REFERENCE E-COMPLAINT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495221 LEEP SYSTEM 1000 ESU GEN. 110V L1000 HGI COOPERSURGICAL, INC. 52969

    Patients

    Seq Age Sex Outcome Treatment
    1