BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY PRECISION BIPOLAR COAGULATOR

    MDR report key: 3879668 · Received June 18, 2014

    Report

    Report Number
    1226348-2014-11714
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 23, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    GEI
    PMA / PMN Number
    PK951985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    SUPPLIER EVALUATION REVEALED : WE COULD NOT DUPLICATE CUSTOMER'S COMPLAINT. UNIT AS RECEIVED WAS FULLY OPERATIONAL. UNIT REQUIRES UPDATE PER ECO 753. PROBLEM WAS DUPLICATED AT LINE VOLTAGES OF 84 VAC AND LOWER. NOTE: PROBLEMS POSSIBLY DUE TO LOW LINE VOLTAGE. FIX: REPLACED WORN RF OUTPUT JACKS. UPDATED PER ECO 753. RETESTED UNIT PER DOC # QAK-045. UNIT PASSED ON FINAL ACCEPTANCE TEST. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    THE OUTPUT LEVEL WAS DECREASED DURING SURGERY. IT WAS NOTED THE SAME PHENOMENON BEFORE WITH THIS DEVICE. IT WAS REPORTED THAT THE PLUG OF THE DEVICE WAS CONNECTED TO THE WALL. NO HIGH FREQUENCY EQUIPMENT WAS NEAR THE DEVICE AS WELL. THE CUSTOMER REQUESTS FURTHER INVESTIGATION BY THE SUPPLIER AND FOR THE RETURN AFTER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358009 SYNERGY PRECISION BIPOLAR COAGULATOR ELECTROSURG. CUTTING & COAG. DEVICE & ACC. GEI CODMAN & SHURTLEFF SYN4242

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention