BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARGLIDE PRECISION BIPOLAR

    MDR report key: 1532911 · Received November 3, 2009

    Report

    Report Number
    1718850-2009-00074
    Event Type
    Malfunction
    Date Received
    November 3, 2009
    Date of Event
    October 6, 2009
    Report Date
    October 8, 2009
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K003587
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INFORMATION IS MADE AVAILABLE. THIS ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE WAS MANUFACTURED BY DATASCOPE CORPORATION LOCATED IN (B) (4). SORIN GROUP USA HAS SINCE ACQUIRED THIS PRODUCT LINE. SORIN GROUP USA IS FILING THIS REPORT ON BEHALF OF DATASCOPE. THE CLINICIAN REPORTED THAT THE JAW TIP BROKE OFF THE ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE. THE JAW TIP WAS RECOVERED. THERE WAS NO REPORT OF PATIENT INJURY. THE BIPOLAR DEVICE WAS RETURNED TO SORIN GROUP USA FOR EVALUATION. VISUAL INSPECTION CONFIRMED THAT THE TIP OF THE UPPER JAW WAS BROKEN OFF. THE MANUFACTURING RECORDS WERE REVIEWED. THE DEVICE MET ALL RAW MATERIALS, IN-PROCESS AND FINISHED GOODS SPECIFICATIONS UPON RELEASE. NO ABNORMALITIES WERE NOTED. THE CAUSE FOR THE BROKEN JAW COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE DEVICE WAS DAMAGED DURING USE. THE INSTRUCTIONS FOR USE STATE "DO NOT ADVANCE OR TORQUE THE INSTRUMENT WITH THE JAWS OPEN OR USE THE JAWS FOR SPREAD DISSECTION. THESE ACTIONS WILL DAMAGE THE INSTRUMENT."

    Description of Event or Problem · 1

    THE CLINICIAN REPORTED THAT THE JAW TIP BROKE OFF THE ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE. THE JAW TIP WAS RECOVERED. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARGLIDE PRECISION BIPOLAR BIPOLAR DEVICE GEI DATASCOPE CORPORATION NA 12728

    Patients

    Seq Age Sex Outcome Treatment
    1