BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACE+7 LAPAROSCOPIC SHEARS

    MDR report key: 6185885 · Received December 13, 2016

    Report

    Report Number
    MW5066775
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    December 12, 2016
    Report Date
    December 13, 2016
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    NLQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HARMONIC SCALPEL FAILED DURING CASE, NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819825 ACE+7 LAPAROSCOPIC SHEARS HARMONIC SCALPEL NLQ ETHICON ENDO SURGERY HARH36 N9339F

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR