BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP SYSTEM 1000 ESU GEN.

    MDR report key: 6307153 · Received February 7, 2017

    Report

    Report Number
    1216677-2016-00090
    Event Type
    Malfunction
    Date Received
    February 7, 2017
    Date of Event
    November 15, 2016
    Report Date
    December 15, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K952483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    REF.#: (B)(4). REPORT AS PER REQUEST FROM FDA MEDWATCH PROGRAM. THIS IS TO BRING TO YOUR ATTENTION THAT WE ARE IN RECEIPT OF SEVERAL SUPPLEMENT REPORTS SUBMITTED BY COOPER SURGICAL, INC., PLEASE BE INFORMED THAT THERE IS NO RECORD OF INITIAL REPORT SUBMISSIONS IN EMDR SYSTEM. IT APPEARS THAT FOLLOW-UP #1 COULD BE ACTUAL INITIAL REPORT, BUT MAY HAVE BEEN ERRONEOUSLY SUBMITTED AS FOLLOW-UP IN ERROR. KINDLY VERIFY THE SUPPLEMENT REPORTS LISTED BELOW, AND RESUBMIT FOLLOW-UP #1 REPORT AS INITIAL REPORT ELECTRONICALLY THROUGH ESG WEB TRADER BY CHECKING ONLY "INITIAL" BOX, AND ADVISE WHEN COMPLETE.

    Description of Event or Problem · 1

    REVIEW OF SERVICE AND REPAIR LOG #: 84194. FOLLOW UP QUESTIONNAIRE: "INTERMITTENT FAILURE TO CAUTERIZE." REFERENCE COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92608 LEEP SYSTEM 1000 ESU GEN. LEEP 1000, HGI COOPERSURGICAL, INC. 52969

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other