BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEPROBE

    MDR report key: 2760413 · Received September 18, 2012

    Report

    Report Number
    2936485-2012-00490
    Event Type
    Malfunction
    Date Received
    September 18, 2012
    Date of Event
    August 23, 2012
    Report Date
    August 27, 2012
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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 PROCEDURE, THE TIP OF THE ELECTROCAUTERY PROBE UNIT BROKE OFF. THE TIP OF THE UNIT WAS LOST IN THE PT FOR ABOUT 10 TO 15 MINUTES. THE TIP WAS FOUND AND RETRIEVED CAUSING AND INCREASE TIME THE PT REMAINED ON THE OPERATING TABLE. NO OTHER COMPLICATIONS WERE REPORTED. THE ACCOUNT FURTHER STATED THAT THE UNIT HAS SCRATCH MARKS CAUSED WHILE THE TIP WAS BEING REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKEPROBE ELECTROCAUTERY PROBE GEI STRYKER ENDOSCOPY SAN JOSE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK