BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP SYSTEM 1000-110V

    MDR report key: 5612975 · Received April 27, 2016

    Report

    Report Number
    1216677-2015-00077
    Event Type
    Malfunction
    Date Received
    April 27, 2016
    Date of Event
    August 21, 2015
    Report Date
    November 9, 2016
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K952483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 0

    REVIEW OF SERVICE AND REPAIR ORDER LOG 79765: PER REPAIR AUTHORIZATION FORM: "ONLY ENGAGES FOR 2 SECONDS, WON'T KEEP CUTTING." REFERENCE E-COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). PLEASE FIND ATTACHED THE (B)(4) FINAL MDR SUBMISSION PACKAGE , REGARDING ALL INITIAL MDR'S ,AND RETRO REVIEW INITIAL MDR'S FILED FOR REPORTS OF INTERMITTENT FUNCTION DURING USE. THE DOCUMENTS INCLUDED IN THIS PACKAGE ARE AS FOLLOWS: · (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

    REVIEW OF SERVICE AND REPAIR ORDER LOG (B)(4): PER REPAIR AUTHORIZATION FORM: "ONLY ENGAGES FOR 2 SECONDS, WON'T KEEP CUTTING." (B)(4).

    Description of Event or Problem · 1

    REVIEW OF SERVICE AND REPAIR ORDER LOG (B)(4): PER REPAIR AUTHORIZATION FORM: "ONLY ENGAGES FOR 2 SECONDS, WON'T KEEP CUTTING." REFERENCE E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268036 LEEP SYSTEM 1000-110V L1000 HGI COOPERSURGICAL, INC. L1000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1