BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM X 32CM STRYKEPROBE SPOON TIP

    MDR report key: 3020672 · Received March 26, 2013

    Report

    Report Number
    0002936485-2013-00100
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 1, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K963765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. INSTEAD DEVICE (B)(4) STRYKER PROBE L-TIP WAS RETURNED AND EVALUATED. THE RETURNED UNIT WAS CONFIRMED TO HAVE A TIP BREAKAGE. THE POSSIBLE ROOT CAUSES (BASED ON PREVIOUS COMPLAINTS): INSUFFICIENT PARAMETERS AT SOLDER PROCESS, AND/OR SOLDER FATIGUE DUE TO HIGHER TEMPERATURES USED IN STERILIZATION PROCESS. HOWEVER, THIS COULD NOT BE VERIFIED. IN SUM, THE REPORTED PRODUCT WAS NOT RETURNED FOR INVESTIGATION, SO THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. ANOTHER DEVICE WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED ON THIS DEVICE. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BROKE. MORE INFORMATION WAS REQUESTED BUT HAS YET TO BE RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BROKE. MORE INFORMATION WAS REQUESTED BUT HAS YET TO BE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123705 5MM X 32CM STRYKEPROBE SPOON TIP ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 12B0357

    Patients

    Seq Age Sex Outcome Treatment
    1