BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX ULTRA SHEARS LONG

    MDR report key: 1302225 · Received December 2, 2008

    Report

    Report Number
    1219930-2008-00873
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Date of Event
    November 18, 2008
    Report Date
    November 28, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    LFL
    PMA / PMN Number
    K971861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MDR INITIAL REPORT SUBMITTED: 12/02/2008.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: JAWS SHEARED OFF COMPLETELY INSIDE PATIENT. SURGEON WAS ABLE TO RETRIEVE TIP FROM PATIENT. PATIENT FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRA SHEARS LONG ENERGY DEVICE LFL NORTH HAVEN - USS N7J95

    Patients

    Seq Age Sex Outcome Treatment
    1