BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIB CUTTER

    MDR report key: 4596 · Received February 25, 1993

    Report

    Report Number
    4596
    Event Type
    Injury
    Date Received
    February 25, 1993
    Date of Event
    April 29, 1992
    Report Date
    May 1, 1992
    Manufacturer
    V. MUELLER
    Product Code
    HIN
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    RIB CUTTER WAS USED ON A FIRST RIB RESECTION IN THE APPROPRIATE MANNER AND AS IT WAS BEING WITHDRAWN FROM THE INCISION, IT WAS NOTED THAT THE RIB CUTTER HAD BROKEN WITH A PIECE FLLING INTO THE PATIENT'S PLEURAL CAVITY.THE PIECE WAS RETREIVED FROM PATIENR'S PLUERAL CAVITY AND CHEST TUBE INSERTEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: OTHER. RESULTS OF EVALUATION: OTHER. CONCLUSION: OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NO DATA. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIB CUTTER HIN V. MUELLER N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention