BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM 50-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 4221671 · Received November 3, 2014

    Report

    Report Number
    0002936485-2014-00874
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K071859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF DEVICE, A NEW FAILURE MODE OF HEAT SHRINK DAMAGE HAS BEEN IDENTIFIED, THUS CONSTITUTING A NEW AWARENESS DATE. BLOCK G4 HAS BEEN UPDATED ACCORDINGLY.ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED INSULATION DAMAGE WAS CONFIRMED ON THE RETURNED UNIT. THE PROBABLE ROOT CAUSES FOR THE REPORTED CONDITION CAN BE ASSOCIATED, BUT ARE NOT LIMITED TO: NON CONFORMING COMPONENT. ACCORDING TO THE DEVICE HISTORY RECORD REVIEW, THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. POOR ASSEMBLY PROCESS. THE PROBE IS DELIVERED INSIDE A BLISTER IN WHICH THE UNIT IS SNAPPED IN PLACE, AND THE BLISTER IS PLACED INSIDE A BOX, WHICH PROVIDES THE REQUIRED PROTECTION TO PREVENT ANY DAMAGE TO THE PROBE AFTER MANUFACTURING AND PACKAGING. MISUSE. AFTER PERFORMING THE VISUAL INSPECTION ON THE RETURNED UNIT, THE FOLLOWING WAS OBSERVED: THE INSULATION WAS TORN IN CIRCULAR MOTION AROUND THE WAND. IMPACT AND SCRATCH WEAR MARKS CAN BE OBSERVED ALL AROUND THE INSULATION THAT IS STILL IN PLACE COVERING THE LUMEN. LONG LINEAR SCRATCH MARKS ARE OBSERVED ON THE RIGHT SIDE OF THE PROBE (ELECTRODE FACING FORWARD), FROM THE CERAMIC ALL THE WAY DOWN THE LUMEN. A SLIGHT CURVATURE CAN BE OBSERVED IN THE LUMEN (BENT). THE MARKS OBSERVED, THE BENT LUMEN AND THE CIRCULAR INSULATION TARRING ARE INDICATIVE THAT THE UNIT MUST HAVE BEEN IN CONTACT WITH A POINTY OBJECT OR A SHARP INSTRUMENT (E.G. CUTTER OR SHAVER, HARD TISSUE, OR BONE) OR THAT THE UNIT COULD HAVE BEEN USED AS A TOOL FOR THE MECHANICAL DISPLACEMENT OF TISSUE OR BONE, FRICTION OR SCRAPPING WITH ANOTHER HARD OBJECT BEFORE IT WAS FIRED, WHICH CAN RESULT IN THE DAMAGE OBSERVED AND IT IS CONTRAINDICATED AS PER USER INSTRUCTIONS FOR THE SERFAS ENERGY PROBES FAMILY. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT DOES NOT CONNECT OR FIT PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT DOES NOT CONNECT OR FIT PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703167 3.5MM 50-S SERFAS ENERGY SUCTION PROBE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 14210AE2

    Patients

    Seq Age Sex Outcome Treatment
    1