BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSONIX HOOK PROBE LONG

    MDR report key: 2021605 · Received March 10, 2011

    Report

    Report Number
    1219930-2011-00197
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 3, 2011
    Report Date
    March 2, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    LFL
    PMA / PMN Number
    K971861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP CHOLE. ACCORDING TO THE REPORTER: DURING THE CASE, THE TIP OF THE DEVICE WAS BROKEN. THE OPERATOR SHOULD NOTE THIS, BUT THE STAFF FAILS TO FIND THE HEAD DURING SURGERY. AFTER THE SURGERY, THE PT SUFFERED FROM INTERNAL BLEEDING. LATER IN THE EVENING, THE PT WAS RE-OPERATED ON BECAUSE OF THE BLEEDING. THIS IS WHEN THE OPERATOR CONSIDERS THE LACK OF ULTRASONIC TIP. THE SURGEON HAS STATED THE BLEEDING WAS NOT CAUSED BY THE BROKEN PIECE FROM THE INSTRUMENT. THE BROKEN PIECE WAS FOUND AND RETRIEVED FROM THE PT'S CAVITY DURING THE RE-OPERATION. A NEW INSTRUMENT WAS USED TO FINISH THE PROCEDURE. THE PT'S STAY IN THE HOSPITAL WAS NOT PROLONGED DUE TO THE PROBLEM AND POST-OPERATIVELY THE PT'S CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX HOOK PROBE LONG DISPOSABLE SURGICAL DEVICE LFL UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention