BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVH

    MDR report key: 9044415 · Received September 13, 2019

    Report

    Report Number
    2242352-2019-01034
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Date of Event
    August 20, 2019
    Report Date
    September 13, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K043155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. AN INVESTIGATION WAS CONDUCTED ON 11/15/2019. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. NO VISUAL DEFECTS WERE OBSERVED. AN ELECTRICAL EVALUATION WAS PERFORMED. THE RETURNED CABLE WAS CONNECTED TO A REFERENCE POWER SUPPLY AND A REFERENCE HEMOPRO. A PRE-CAUTERY TEST WAS CONDUCTED PER THE INSTRUCTION FOR USE (IFU) TO TEST THE ABILITY OF THE EXTENSION WIRE TO DELIVER ENERGY. THE REFERENCE HEMOPRO TOOL PASSED THE PRE-CAUTERY TEST. IT PRODUCED VISIBLE STEAM DURING SEVERAL ACTIVATIONS OVER A PERIOD OF 10 MINUTES AND SHUT OFF WHEN THE TOGGLE WAS RELEASED. BASED ON THE RETURNED CONDITION OF THE DEVICE AND THE RESULTS OF THE EVALUATION, THE REPORTED FAILURE MODE "FAILURE TO DELIVER ENERGY" WAS NOT CONFIRMED. THIS IS A REUSABLE OEM DEVICE. THEREFORE, A LOT /SERIAL HISTORY REVIEW WAS NOT APPLICABLE. A SERIAL/LOT NUMBER WAS NOT PROVIDED AND THE SPECIFIC PRODUCT SERIAL/LOT 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 DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, HEMOPRO EXTENSION CABLE FAILED TO ACTIVATE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    TRACKWISE #(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 DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, HEMOPRO EXTENSION CABLE FAILED TO ACTIVATE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819300 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC DC EXTENSION CABLE

    Patients

    Seq Age Sex Outcome Treatment
    1