BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RP 360 DEGREE SUTURE PASSER

    MDR report key: 1962797 · Received January 13, 2011

    Report

    Report Number
    3004086872-2011-00001
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 13, 2011
    Manufacturer
    IMDS
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION: EVAL SUGGESTS USE OR TECHNIQUE ERROR, HOWEVER, NO EVIDENCE EXISTS THAT WOULD ALLOW THIS STATEMENT TO BE MADE CONCLUSIVELY. CONCLUSION: EVIDENCE SUGGESTS THAT THE FAILED UNIT WAS HANDLED IN SUCH A WAY AS TO HYPEREXTEND THE UPPER JAW. POSSIBLE CAUSE OF HYPEREXTENSION IS UNK, BUT POSSIBLE CAUSE COULD INCLUDE DROPPED INSTRUMENT, MISHANDLING WHEN PLACING THE INSTRUMENT ON/IN A TRAY, OR CATCHING THE UPPER JAW ON SOMETHING DURING NORMAL USE.

    Description of Event or Problem · 1

    JAW HINGE PIN IN THE INSTRUMENT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RP 360 DEGREE SUTURE PASSER SURGICAL INSTRUMENT MDM IMDS 3910-900-090 W07243

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention