BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUTTER, WIRE

    MDR report key: 10343568 · Received July 30, 2020

    Report

    Report Number
    10343568
    Event Type
    Injury
    Date Received
    July 30, 2020
    Date of Event
    July 16, 2020
    Report Date
    July 24, 2020
    Manufacturer
    BOSS INSTRUMENTS LTD
    Product Code
    HXZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AN ADULT FEMALE WAS UNDERGOING A T3-ILIUM POSTERIOR SPINAL FUSION. THE BOLT CUTTER BROKE, AND A SMALL PIECE OF IT FELL INTO THE LEFT CHEST THOUGH THE SPINE INCISION. CT SURGERY WAS CONSULTED INTRA-OPERATIVELY TO ASSIST WITH REMOVAL. THIS NECESSITATED OVER SEWING AND STAPLING OF A HOLE IN THE LUNG PARENCHYMA, PARTIAL LUNG RESECTION, AND LEFT CHEST TUBE PLACEMENT WAS DONE AND THE FOREIGN BODY WAS FOUND. THERE WAS BLEEDING IN THIS AREA THAT REQUIRED 4L INTRAVENOUS FLUIDS, 4 UNITS OF PACKED RED BLOOD CELLS, 1-UNIT FRESH FROZEN PLASMA, 1-UNIT PLATELETS. PATIENT NEEDED A CHEST TUBE AND REQUIRED AN ICU ADMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810093 CUTTER, WIRE HXZ BOSS INSTRUMENTS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 7300 DA Hospitalization| R