BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVH

    MDR report key: 8866360 · Received August 6, 2019

    Report

    Report Number
    2242352-2019-00898
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    July 12, 2019
    Report Date
    August 6, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE #: (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. AN INVESTIGATION WAS CONDUCTED ON 10/11/2019. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. THE ONE CONNECTOR WAS OBSERVED TO BE BENT AND TAPED TO THE END OF THE CORD. THE OTHER CONNECTOR WAS OBSERVED TO BE INTACT, NO VISUAL DEFECTS WERE OBSERVED. BASED ON THE RETURNED CONDITION OF THE DEVICE, THE REPORTED FAILURE "BREAK; CORD" WAS CONFIRMED. THIS IS A REUSABLE OEM DEVICE; THEREFORE, A LOT HISTORY/SERIAL NUMBER REVIEW WAS NOT APPLICABLE. A LOT/SERIAL NUMBER WAS NOT PROVIDED AND THE SPECIFIC PRODUCT LOT/SERIAL NUMBER CANNOT BE IDENTIFIED FROM A SHIP HISTORY, THEREFORE IT IS IMPOSSIBLE TO OBTAIN A CERTIFICATE OF CONFORMANCE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT POST USE AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING HEMOPRO2 EXTENSION CABLE. THEY STATED THAT WHEN THEY WERE REMOVING THE HEMOPRO 2 EXTENSION CABLE FROM THE HEMOPRO 2 DEVICE, THE END OF THE CABLE BROKE OFF. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT POST USE AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING HEMOPRO2 EXTENSION CABLE. THEY STATED THAT WHEN THEY WERE REMOVING THE HEMOPRO 2 EXTENSION CABLE FROM THE HEMOPRO 2 DEVICE, THE END OF THE CABLE BROKE OFF. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657334 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC HEMOPRO2 EXTENSION CABLE 4030

    Patients

    Seq Age Sex Outcome Treatment
    1