BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALO PKS CUTTING FORCEPS

    MDR report key: 2193602 · Received July 14, 2011

    Report

    Report Number
    2183680-2011-00024
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 14, 2011
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME GYRUS (B)(4) IS UNABLE TO DETERMINE THE EXACT CAUSE OF THE CUSTOMER'S COMPLAINT OF REQUIRING NUMEROUS TOUCH UP ON BLEEDERS THROUGH OUT THE CASE. ANALYSIS OF THE DEVICE HAS OBSERVED THAT THE JAWS NOT CLOSING COMPLETELY. AN ON-GOING INVESTIGATION INTO THIS COMPLAINT MODE IS IN PROGRESS WITH TEAM MEMBERS OF THE VALUE STREAM AND DESIGN ENGINEERING. WE WILL CONTINUE TO MONITOR FOR FURTHER OCCURRENCES.

    Description of Event or Problem · 1

    DURING A TLH SURGICAL PROCEDURE, THE SURGEON OBSERVED THAT THE PT REQUIRED RE-TOUCH UP THROUGHOUT THE CASE. NOTICED THAT THE JAWS DID NOT SEEM TO CLOSE EVENLY, LOWER JAW APPEARED TO BE DOWNWARD STRAIGHT OUT OF THE PACKAGE. SURGEON USED THE DEVICE FOR THE ENTIRE CASE TO FINISH THE PROCEDURE WITHOUT ANY HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO PKS CUTTING FORCEPS HALO PKS CUTTING FORCEPS GEI GYRUS MEDICAL, INC. HACF0533 328147ED

    Patients

    Seq Age Sex Outcome Treatment
    1