BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.R. BOOM, MMP200

    MDR report key: 2141329 · Received June 1, 2011

    Report

    Report Number
    2031963-2011-00040
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT, THUS NO PT DATA EXISTS. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. THERE IS NO SERIAL NUMBER OR DATE OF MANUFACTURE BUT THE ENTIRE UNIT WAS INSTALLED AT THE ACCOUNT ON (B)(6) 2008. ACTUAL DEVICE WAS EVALUATED ON SITE BY A FIELD SERVICE REPRESENTATIVE. EVAL SUMMARY: IT WAS REPORTED, THE END CAP FELL INTO A STERILE FIELD AND IMPACTED A STERILE SURGICAL TRAY. THE END CAP IS A NON-STERILE COMPONENT. ALTHOUGH THE FAILURE DID NOT DIRECTLY CAUSE OR CONTRIBUTE TO AN INJURY, THERE IS A POTENTIAL FOR THIS TO CAUSE OR CONTRIBUTE TO A HEALTH CONCERN. THE STAFF QUARANTINED THE AREA AND OPENED ANOTHER STERILE TRAY. WHILE THERE WAS NO DIRECT CONTACT WITH THE PT IN THIS CASE, THE POTENTIAL EXISTS FOR THE END CAP TO DROP ONTO OR INTO THE PT DURING SURGERY. THERE WAS NO DIRECT PT INVOLVEMENT OR SERIOUS ADVERSE CONSEQUENCES REPORTED WITH THIS OCCURRENCE. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THE SPRING ARM ELBOW COVER NEAR THE EXTENSION ARM JOINT FELL DURING A CASE. IT WAS FURTHER REPORTED THAT IT HIT A STERILE TRAY AND THE STAFF QUARANTINED THE AREA AND OPENED A NEW SURGICAL TRAY. THE COVER WAS DAMAGED BY COLLISION WITH OTHER EQUIPMENT AND THE REMOVED THE COVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O.R. BOOM, MMP200 BRY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA