BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 3090421 · Received May 2, 2013

    Report

    Report Number
    0002936485-2013-00192
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    March 14, 2013
    Report Date
    April 2, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K071859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS CONFIRMED THAT THE UNIT WAS DISCARDED. HENCE, THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORD OF THIS LOT DISCLOSED NO DISCREPANCIES THAT COULD CONTRIBUTE TO THIS CONDITION. PROBABLE ROOT CAUSES FOR THE REPORTED CONDITION CAN BE ASSOCIATED, BUT ARE NOT LIMITED TO: ASSEMBLY PROCESS AND/OR MISUSE. IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE METALLIC DISTAL TIP WAS LOST INSIDE THE PATIENTS SHOULDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE METALLIC DISTAL TIP WAS LOST INSIDE THE PATIENTS SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192040 3.5MM 90-S SERFAS ENERGY SUCTION PROBE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 12279AE2

    Patients

    Seq Age Sex Outcome Treatment
    1