BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONX

    MDR report key: 17535828 · Received August 12, 2023

    Report

    Report Number
    MW5142722
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    September 1, 2020
    Report Date
    October 28, 2020
    Manufacturer
    UNKNOWN
    Product Code
    OTJ
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A LAP SCISSOR OF WHICH THE SCISSOR TIP WAS NOT COMPLETELY INTACT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785016 SYMPHONX LAPAROSCOPIC SINGLE PORT ACCESS DEVICE OTJ UNKNOWN "001522698"

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown