BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP SYSTEM 1000 ESU GEN.

    MDR report key: 4938462 · Received July 22, 2015

    Report

    Report Number
    1216677-2015-00015
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    March 26, 2013
    Report Date
    April 14, 2015
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    COOPERSURGICAL, INC. SERVICE AND REPAIR LOG NUMBER 69846. A RETROSPECTIVE REVIEW OF THE REPORTED COMPLAINT CONDITION: "FOOT PEDAL NOT ACTIVATING UNIT" INDICATES A PRODUCT MALFUNCTION WHICH COULD POSSIBLY NECESSITATE INTERVENTION TO ACHIEVE DESIRED OUTCOME. REFERENCE E-COMPLAINT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476977 LEEP SYSTEM 1000 ESU GEN. LEEP SYSTEM 1000 ESU GEN. HGI COOPERSURGICAL, INC. 52969

    Patients

    Seq Age Sex Outcome Treatment
    1