BEUDAMED
    FDA Adverse Event Other Summary report: N

    VC EVH, OD, SMR, VD, BP

    MDR report key: 2268945 · Received September 22, 2011

    Report

    Report Number
    1718850-2011-00104
    Event Type
    Other
    Date Received
    September 22, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    GEI
    PMA / PMN Number
    K102983
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED BY THE FACILITY. WITHOUT THE LOT NUMBER, THE EXPIRATION DATE CAN NOT BE DETERMINED. THE LOT NUMBER WAS NOT PROVIDED BY THE FACILITY. WITHOUT THE LOT NUMBER, THE MFG DATE CAN NOT BE DETERMINED. SORIN GROUP (B)(4) RECEIVED A REPORT THAT DURING THE VEIN HARVESTING PROCEDURE, THE BLUE JAW BROKE FREE FROM THE BIPOLAR DEVICE. THE BIPOLAR DEVICE WAS REPLACED. THERE WAS NO NEGATIVE IMPACT TO THE PT AS A RESULT OF THE EVENT. SORIN GROUP (B)(4) HAS REQUESTED THAT THE PRODUCT BE RETURNED FOR EVAL. TO DATE NO PRODUCT HAS BEEN RECEIVED. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT DURING THE VEIN HARVESTING PROCEDURE, THE BLUE JAW BROKE FREE FROM THE BIPOLAR DEVICE. THE BIPOLAR DEVICE WAS REPLACED. THERE WAS NO NEGATIVE IMPACT TO THE PT AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VC EVH, OD, SMR, VD, BP BIPOLAR DEVICE GEI SORIN GROUP USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1