BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTOPUS NUVO TISSUE STABALIZER

    MDR report key: 1654644 · Received April 5, 2010

    Report

    Report Number
    2135394-2010-00005
    Event Type
    Injury
    Date Received
    April 5, 2010
    Date of Event
    March 2, 2010
    Report Date
    March 2, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). METHOD: DEVICE HISTORY WAS NOT REVIEWED, AS THE SERIAL NUMBER WAS NOT AVAILABLE AND NO PRODUCT WAS RETURNED FOR ANALYSIS. RESULTS: DEVICE HISTORY WAS NOT REVIEWED, AS THE SERIAL NUMBER WAS NOT AVAILABLE AND NO PRODUCT WAS RETURNED FOR ANALYSIS. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED FOR ANALYSIS. SHOULD THE PRODUCT BE RETURNED, OR ADDITIONAL INFO MADE AVAILABLE, THE EVENT WILL BE UPDATED AND A SUPPLEMENTAL REPORT FILED. CONCLUSION: BASED ON THE LIMITED INFO AVAILABLE, NO CAUSE CAN BE DETERMINED FOR THIS EVENT AT THIS TIME.

    Description of Event or Problem · 1

    MEDTRONIC CARDIOVASCULAR RECEIVED INFO THAT DURING A PROCEDURE, THE HEADLINK OF THIS NUVO WAS ATTACHED TO THE SHAFT BY UTILIZING A MEDIUM SIZED LONG NEEDLE HOLDER PLACED AT THE NECK OF THE BALL JOINT BETWEEN THE COLLET AND HEADLINK. AS IT WAS BEING INTRODUCED INTO THE THORACOTOMY, THE COLLET HIT THE RETRACTOR BLADE AND POPPED OFF THE BALL JOINT AND FELL INTO THE CHEST CAVITY. THE PIECE WAS SUCCESSFULLY FOUND ON THE PERICARDIUM BY THE DIAPHRAGM AND WAS REMOVED. THERE WAS NO ADVERSE PT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTOPUS NUVO TISSUE STABALIZER DWS MEDTRONIC PERFUSION SYSTEMS TSMICS1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R