BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY PRECISION BIPOLAR COAGULATOR

    MDR report key: 4521553 · Received February 17, 2015

    Report

    Report Number
    1226348-2015-10093
    Event Type
    Injury
    Date Received
    February 17, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GEI
    PMA / PMN Number
    PK951985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    WE WERE ABLE TO DUPLICATE CUSTOMER'S COMPLAINT. AS RECEIVED, UNIT HAD LOW RF OUTPUT POWER ON TEST. PROBLEM WAS ISOLATED TO A BROKEN SOLDER ON Q107 (TRANSISTOR) ON MAIN BD. UNIT APPEARS TO HAVE BEEN DROPPED; CHASSIS AND COVER WERE BADLY DENTED. ALSO CHASSIS SCREEN HAS A BROKEN WELD. UNIT REQUIRES UPDATE PER ECO 753 (ADD RTV'S L1, L2, L3). A DHR REVIEW WAS PERFORMED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. FIX: REPLACED WORN RF OUTPUT JACKS. SECURED BROKEN (CHASSIS SCREEN) WELD WITH SCREW AND NUT. RE-SOLDERED BROKEN SOLDER Q107 TRANSISTOR ON MAIN BD. RETESTED UNIT PER DOC # QAK-045. UNIT PASSED ON FINAL ACCEPTANCE TEST. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    CUSTOMER STATES THEIR MALIS SYNERGY HAS LOW OUTPUTS, THEY WILL BE SENDING IN THE UNIT FOR REPAIR AND EVALUATION.NO PATIENT HARM.NO DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114678 SYNERGY PRECISION BIPOLAR COAGULATOR ELECTROSURG, CUTTING & COAG. DEVICE & ACC. GEI CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention