BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L1000J 100 VOLT LEEP 1000 GENERA

    MDR report key: 5612504 · Received April 27, 2016

    Report

    Report Number
    1216677-2015-00062
    Event Type
    Malfunction
    Date Received
    April 27, 2016
    Date of Event
    June 10, 2013
    Report Date
    November 7, 2016
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CONCLUDES COOPERSURGICAL' S ROOT CAUSE INVESTIGATION.COOPERSURGICAL, INC. WILL CONTINUE TO MONITOR THE COMPLAINT CONDITION FOR TENDING AND SAFETY.

    Description of Event or Problem · 1

    (B)(4). RETROSPECTIVE REVIEW - REFERENCE REPAIR LOG NUMBER (B)(4). PER REPAIR AUTHORIZATION FORM: "STEPPING ON THE FOOT SWITCH FOR ON AND OFF OFTEN FAILED TO TURN ON."

    Description of Event or Problem · 1

    (B)(4). PER REPAIR AUTHORIZATION FORM:"STEPPING ON THE FOOT SWITCH FOR ON AND OFF OFTEN FAILED TO TURN ON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267762 L1000J 100 VOLT LEEP 1000 GENERA L1000J 100 VOLT LEEP 1000 GENERA HGI COOPERSURGICAL, INC. L1000J N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other