BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR

    MDR report key: 7966738 · Received October 15, 2018

    Report

    Report Number
    1216677-2018-00059
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    July 20, 2018
    Report Date
    October 15, 2018
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K963653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    *INVESTIGATION X-REVIEW DHR X-INSPECT RETURNED SAMPLES *ANALYSIS AND FINDINGS A REVIEW OF THE 2 YR COMPLAINT HISTORY REVEALS SIMILAR ISSUES. A REVIEW OF THE DHR REVEALS NO ANOMALIES. SERVICE & REPAIR DID NOT CONFIRM THE COMPLAINT. NO ISSUES NOTED WITH THE UNIT'S FUNCTION OR THE FOOT PEDAL. THE UNIT OPERATED TO SPECIFICATIONS. A DEFINITIVE ROOT CAUSE IS NOT AVAILABLE FOR THIS COMPLAINT CONDITION. IT IS POSSIBLE THE FOOT PEDAL WAS IMPROPERLY USED. *CORRECTION AND/OR CORRECTIVE ACTION THE UNIT WAS UPDATED WITH A DIODE PER THE CURRENT BOARD REVISION AND RETURNED TO THE CUSTOMER. ALSO, THE FOOT PEDAL WAS REPLACED AS A PRECAUTION. THE CHANGE WAS EXECUTED VIA (B)(4). *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    FOOT PEDAL IS ONLY INTERMITTENTLY WORKING CURRENT IS COMING ON AND OFF BY ITSELF.

    Additional Manufacturer Narrative · 1

    COOPER SURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE ACTUAL DEVICE INVOLVED IN THE COMPLAINT HAS BEEN RETURNED FOR EVALUATION BY THE CUSTOMER. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILLED. (B)(4).

    Description of Event or Problem · 1

    FOOT PEDAL IS ONLY INTERMITTENTLY WORKING. CURRENT IS COMING ON AND OFF BY ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804986 LEEP PRECISION GENERATOR LP-20-120 HGI COOPERSURGICAL, INC. LP-20-120 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other