BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 2964562 · Received February 15, 2013

    Report

    Report Number
    0002936485-2013-00027
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 23, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K041810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED TIP BREAKING CONDITION WAS CONFIRMED. THE MISSING FLOWER SHAPED ELECTRODE PORTION WAS ALSO RETURNED FOR EVALUATION. THE REST OF THE ELECTRODE WAS VISIBLE INSIDE THE CERAMIC TIP. SOME VISUAL WEAR MARKS WERE OBSERVED ON THE CERAMIC, LUMEN AND INSULATION. REVIEW OF THE DEVICE HISTORY RECORD OF THIS LOT 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 WAS GENERATED AFTER AN INCREASE IN TIP BREAKING CONDITION INCLUDING THIS PART NUMBER WAS OBSERVED. THE PROBABLE ROOT CAUSES FOR THE REPORTED CONDITION CAN BE ASSOCIATED, BUT ARE NOT LIMITED TO: NON CONFORMING COMPONENT, POOR ASSEMBLY PROCESS:, AND/OR MISUSE IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE TIP OF UNIT THAT IS ATTACHED TO THE WAND SEPARATED AND DETACHED. IT WAS FURTHER REPORTED THAT AN X-RAY WAS TAKEN TO IDENTIFY THE LOCATION OF THE TIP. THE SURGEON WAS ABLE TO RETRIEVE THE TIP AND COMPLETE THE PROCEDURE SUCCESSFULLY. AN APPROXIMATE 20 MINUTE DELAY WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE TIP OF UNIT THAT IS ATTACHED TO THE WAND SEPARATED AND DETACHED. IT WAS FURTHER REPORTED THAT AN X-RAY WAS TAKEN TO IDENTIFY THE LOCATION OF THE TIP. THE SURGEON WAS ABLE TO RETRIEVE THE TIP AND COMPLETE THE PROCEDURE SUCCESSFULLY. AN APPROXIMATE 20 MINUTE DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68101 3.5MM 90-S SERFAS ENERGY SUCTION PROBE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 12333AE2

    Patients

    Seq Age Sex Outcome Treatment
    1