BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARB-EDGE METZ SCS 9 CVD

    MDR report key: 6967750 · Received October 22, 2017

    Report

    Report Number
    2523190-2017-00100
    Event Type
    Malfunction
    Date Received
    October 22, 2017
    Date of Event
    September 1, 2017
    Report Date
    September 25, 2017
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    DWS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    ON 10/24/17 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. COMPLAINT IS UNCONFIRMED; THIS IS DUE TO THE PRODUCT NOT BEING RETURNED FOR REVIEW. DEVICE HISTORY EVALUATION - DHR REVIEW NONCONFORMING PRODUCT REPORT/ NONCONFORMING MATERIAL REPORT HISTORY: NONE VARIANCE AUTHORIZATION/DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    FDA SUS VOLUNTARY EVENT REPORT MW5072008 REPORTS THAT THE METAL TIP OF THE SURGICAL JARIT CARB EDGE SCISSOR #101267 BROKE OFF DURING AN ABDOMINAL SURGICAL PROCEDURE X-RAY WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747249 CARB-EDGE METZ SCS 9 CVD CARDIOVASCULAR SCISSORS DWS INTEGRA YORK, PA INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1