BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TW POWER SUPPLY, US

    MDR report key: 2050848 · Received April 1, 2011

    Report

    Report Number
    2242352-2011-00222
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 5, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    HQO
    PMA / PMN Number
    K043155
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MAQUET CARDIOVASCULAR FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE POWER SUPPLY FAILED TO DELIVER ENERGY WITH THE HEMOPRO UNIT. THEY STATED THAT IT WAS CUTTING BUT NOT SEALING WHICH LED TO MINIMAL BLEEDING. THE BLEEDING WAS STOPPED WITH CAUTERIZATION. A REPLACEMENT GENERATOR WAS USED TO COMPLETE THE PROCEDURE WITH THE SAME HEMOPRO AND CABLE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TW POWER SUPPLY, US POWER SUPPLY HQO MAQUET CARDIOVASCULAR, LLC VH-3010 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other