BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVH

    MDR report key: 11378799 · Received February 25, 2021

    Report

    Report Number
    2242352-2021-00182
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    February 16, 2021
    Report Date
    February 23, 2021
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING HEMOPRO2 EXTENSION CABLE. THE HEMOPRO CAUTERY INTERMITTENT CUTOUT. THE HARVESTER EXPERIENCED CUTOUT OF HEMOPRO CAUTERY OPERATION AFTER TRANSITIONING FROM TAKING ENDO RADIAL TO ENDO VEIN. THEY HAD THE POWER SUPPLIES SWITCHED WITH THE LOANER IN THE SECONDARY HEART ROOM. THIS DIDN¿T FIX THE PROBLEM OF INTERMITTENT CUTOUT. THEY STRUGGLED THROUGH THE CASE WITHOUT CHANGING OUT ANYTHING ELSE (IE CORDS OR KITS). NO PATIENT HARM. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    TRACKWISE ID# (B)(4). SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING HEMOPRO2 EXTENSION CABLE. THE HEMOPRO CAUTERY INTERMITTENT CUTOUT. THE HARVESTER EXPERIENCED CUTOUT OF HEMOPRO CAUTERY OPERATION AFTER TRANSITIONING FROM TAKING ENDO RADIAL TO ENDO VEIN. THEY HAD THE POWER SUPPLIES SWITCHED WITH THE LOANER IN THE SECONDARY HEART ROOM. THIS DIDN¿T FIX THE PROBLEM OF INTERMITTENT CUTOUT. THEY STRUGGLED THROUGH THE CASE WITHOUT CHANGING OUT ANYTHING ELSE (IE CORDS OR KITS). NO PATIENT HARM. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274165 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC HEMOPRO2 EXTENSION CABLE 00607567700925

    Patients

    Seq Age Sex Outcome Treatment
    1