BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRO SCORPION NEEDLE SUTURE PASSER

    MDR report key: 9720664 · Received February 14, 2020

    Report

    Report Number
    MW5093022
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    February 5, 2020
    Report Date
    February 12, 2020
    Manufacturer
    CAYENNE MEDICAL INC.
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TIP OF NEEDLE USED DURING SURGICAL CASE BROKE OFF. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177985 QUATTRO SCORPION NEEDLE SUTURE PASSER NEEDLE, SUTURING, DISPOSABLE GAB CAYENNE MEDICAL INC. CM-9011 70113-1

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR