BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 3930196 · Received July 11, 2014

    Report

    Report Number
    0002936485-2014-00479
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 20, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K071859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE TIP BREAKING CONDITION (ELECTRODE) 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: IN ADDITION, A 30X INSPECTION OF THE PROBE¿S TIP ASSEMBLY IS PERFORMED ON ALL THE PROBES DURING MANUFACTURING. THE ACTIVATION HISTORY SHOWED THAT THE UNIT WAS AT LEAST 46 TIMES (41 PLUS THE FIRST FIVE) OR MORE, WHICH IS THE MAXIMUM ACTIVATION INSTANCES DATA STORAGE FOR A MINIMUM OF 159 BEFORE THE ELECTRODE FELL OFF, WHICH INDICATES THAT THE UNIT WAS ASSEMBLED PROPERLY AND WAS FULLY OPERATIONAL FOR AN EXTENDED PERIOD OF TIME. MISUSE: 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 PROTECTION TO THE TIP OF THE PROBE. IN THE EVENT THAT THE PROBE IS DELIVERED TO THE CUSTOMER WITH A DAMAGED TIP, THEN THE UNIT MUST BE DISCARDED BEFORE USE. SCRATCH MARKS CAN BE OBSERVED ON THE CERAMIC, LUMEN AND INSULATION ALL AROUND THE PROBE¿S TIP HOWEVER, THEY ARE MOSTLY CONCENTRATION ON THE FRONT ALIGNED WITH THE ELECTRODE. SCRATCH MARKS ARE ALSO VISIBLE AROUND THE EDGE OF THE INSULATION NEAR THE TIP THE INSULATION. IN ADDITION, SCRATCH WEAR MARKS CAN BE OBSERVED ON THE EXPOSED INNER LUMEN INDICATIVE OF POSSIBLE CONTINUOUS SCRAPPING OF THE TIP AGAINST TISSUE, BONE OR OBJECT, EVEN AFTER THE CERAMIC HAD ALREADY FELL OFF. THEREFORE, A POSSIBLE USER RELATED (MISUSE) POSSIBLE CONTRIBUTOR CANNOT BE RULED OUT. 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 TIP OF THE WAND FELL OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE WAND FELL OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406446 3.5MM 90-S SERFAS ENERGY SUCTION PROBE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1