BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 3041635 · Received April 8, 2013

    Report

    Report Number
    0002936485-2013-00131
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 21, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K071859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED TIP BREAKING FAILURE MODE COULD NOT BE CONFIRMED SINCE THE UNIT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD OF THIS LOT DISCLOSED NO DISCREPANCIES THAT COULD CONTRIBUTE TO THIS CONDITION. HOWEVER, THIS IS A KNOWN FAILURE MODE WITH PROBABLE ROOT CAUSES BE ASSOCIATED, BUT NOT LIMITED TO: NON CONFORMING COMPONENTS, ASSEMBLY PROCESS, AND/OR MISUSE. IN SUM, THE PRODUCT WAS NOT 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 SHOULDER ARTHROSCOPY PROCEDURE, THE SURGEON HAD BEEN USING THE PROBE UNIT. WHEN THE SURGEON REMOVED THE PROBE UNIT FROM THE JOINT AND UPON REINSERTION, HE NOTICED THAT THE TIP OF THE UNIT WAS MISSING. THE SURGEON USED THE ARTHROSCOPE TO SEARCH AND LOCATE THE DISLODGED TIP FROM THE PATIENT'S SHOULDER. A REPLACEMENT UNIT WAS AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FURTHER, NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE SURGEON HAD BEEN USING THE PROBE UNIT. WHEN THE SURGEON REMOVED THE PROBE UNIT FROM THE JOINT AND UPON REINSERTION, HE NOTICED THAT THE TIP OF THE UNIT WAS MISSING. THE SURGEON USED THE ARTHROSCOPE TO SEARCH AND LOCATE THE DISLODGED TIP FROM THE PATIENT'S SHOULDER. A REPLACEMENT UNIT WAS AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FURTHER, NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143637 3.5MM 90-S SERFAS ENERGY SUCTION PROBE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 13009AE2

    Patients

    Seq Age Sex Outcome Treatment
    1