BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNAPTIVE TRACKABLE SUCTION

    MDR report key: 10658700 · Received October 9, 2020

    Report

    Report Number
    3012075008-2020-00006
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    September 17, 2020
    Report Date
    October 9, 2020
    Manufacturer
    SYNAPTIVE MEDICAL INC.
    Product Code
    GCX
    UDI-DI
    00670082000313
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE IS UNKNOWN AT THE TIME OF REPORTING ALTHOUGH CAN BE ATTRIBUTED TO LASER ETCHING ON THE TUBES. MULTIPLE COMPLAINTS WERE REPORTED FROM THE SAME SITE. ISSUE IS EASILY DETECTABLE PRIOR TO USE AND LABELING INSTRUCTIONS ADVISE USER OF THE FOLLOWING: "THE TRACKABLE SUCTION TUBES ARE SEMI-DISPOSABLE AND END OF LIFE IS DETERMINED BY WEAR, DAMAGE AND CORROSION EXPERIENCED DURING USE. ALWAYS INSPECT SUCTION COMPONENTS PRIOR TO USE AND REPLACE IF WORN OR DAMAGED." NOTE: ALL AFFECTED SERIAL NUMBERS AND UDIS HAVE NOT BEEN INCLUDED IN THIS REPORT DUE TO SPACE CONSTRAINTS.

    Description of Event or Problem · 1

    TRACKABLE SUCTION TUBE EXHIBITING SIGNS OF CORROSION AT LOCATIONS WHERE IT HAD BEEN ETCHED. ISSUE WAS DETECTED BY SYNAPTIVE REPRESENTATIVE PRIOR TO SURGERY. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124028 SYNAPTIVE TRACKABLE SUCTION APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX SYNAPTIVE MEDICAL INC. SYN-0675 00670082000313

    Patients

    Seq Age Sex Outcome Treatment
    1