BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARGLIDE PRECIS BIPOLAR

    MDR report key: 1484523 · Received July 31, 2009

    Report

    Report Number
    1718850-2009-00030
    Event Type
    Malfunction
    Date Received
    July 31, 2009
    Date of Event
    June 2, 2009
    Report Date
    July 1, 2009
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K003587
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE WAS MANUFACTURED BY DATASCOPE CORPORATION LOCATED IN NEW JERSEY. SORIN GROUP USA HAS SINCE ACQUIRED THIS PRODUCT LINE. SORIN GROUP USA IS FILING THIS REPORT ON BEHALF OF DATASCOPE. ONE BIPOLAR DEVICE WAS RECEIVED AT SORIN GROUP USA FOR EVALUATION. A VISUAL INSPECTION REVEALED THAT THE TIP OF THE JAW WAS BROKEN OFF, WEDGED IN THE "CUT" BUTTON LOCATED IN THE DEVICE HANDLE. DATASCOPE'S VENDOR OF THE BIPOLAR DEVICE HAS BEEN MADE AWARE OF THIS ISSUE. FURTHER INVESTIGATION IS UNDERWAY. A FOLLOW-UP REPORT WILL BE FILED WHEN INFO IS MADE AVAILABLE.

    Description of Event or Problem · 1

    THE CLINICIAN INITIALLY REPORTED THAT DURING THE PROCEDURE, THE ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE WOULD NOT RELEASE AFTER ENGAGING OVER THE VEIN. HOWEVER, THE RETURNED PRODUCT DID DEMONSTRATE THAT A PIECE OF THE JAW TIP WAS MISSING. NO PT INJURY WAS REPORTED AND THE PT WAS RELEASED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARGLIDE PRECIS BIPOLAR BIPOLAR DEVICE GEI DATASCOPE CORPORATION NA IYZ010913

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR