BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 2931208 · Received January 28, 2013

    Report

    Report Number
    0002936485-2013-00003
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 2, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K041810
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 PRODUCT WAS RETURNED FOR INVESTIGATION. THE TIP BREAKING (ELECTRODE) CONDITION WAS CONFIRMED. THE ELECTRODE WAS NOT RETURNED FOR EVALUATION. SOME VISUAL WEAR AND SCRATCH MARKS WERE OBSERVED ON THE LUMEN, CERAMIC AND INSULATION, INCLUDE WHAT SEEMS TO BE AN IMPACT WEAR MARK NEAR THE PROBE'S TIP. REVIEW OF THE DEVICE HISTORY RECORD OF THIS LOT NUMBER DISCLOSED NO DISCREPANCIES THAT COULD CONTRIBUTE TO THIS CONDITION. NON-CONFORMANCE REPORT HISTORICAL DATA WAS ALSO REVIEWED FOR ANY EVENT ASSOCIATED TO SUBJECT PART NUMBER AND LOT NUMBER IDENTIFIED BY THE CUSTOMER. AN INVESTIGATION IS CURRENTLY IN PROCESS AFTER AN INCREASE IN TIP BREAKING CONDITION INCLUDING THIS PART NUMBER WAS OBSERVED. PROBABLE ROOT CAUSES FOR THE REPORTED CONDITION CAN BE ASSOCIATED, BUT ARE NOT LIMITED TO: NON CONFORMING COMPONENT; POOR ASSEMBLY PROCESS AND/OR MISUSE. BASED ON THE DEVICE HISTORY RECORD, NON-CONFORMANCE REPORT, PREVIOUS COMPLAINT HISTORY AND THE RETURNED UNIT'S EVALUATION, THE MOST PROBABLE ROOT CAUSE IS MULTIFACTORIAL, WITH A POSSIBLE CONTRIBUTOR BEING USER RELATED (MISUSE). IN SUM, 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 UNIT FELL OFF IN THE PATIENT'S SHOULDER. WHILE USING THE UNIT IT WAS NOTICED THAT THE TIP WAS NOT ATTACHED. FURTHER, THE TIP WAS RETRIEVED OUT OF THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE UNIT FELL OFF IN THE PATIENT'S SHOULDER. WHILE USING THE UNIT IT WAS NOTICED THAT THE TIP WAS NOT ATTACHED. FURTHER, THE TIP WAS RETRIEVED OUT OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36792 3.5MM 90-S SERFAS ENERGY SUCTION PROBE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 12304AE2

    Patients

    Seq Age Sex Outcome Treatment
    1