BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRO

    MDR report key: 6380140 · Received March 6, 2017

    Report

    Report Number
    6380140
    Event Type
    Malfunction
    Date Received
    March 6, 2017
    Date of Event
    January 23, 2017
    Report Date
    February 2, 2017
    Manufacturer
    CAYENNE MEDICAL, INC.
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRODUCT COMPLETE INFORMATION: (B)(4), QUATTRO SUTURE PASSER NEEDLE, REF CM-9011, LOT: 59139-1, EXPIRATION: 2019-09-30. ALL STAFF TOOK APPROPRIATE ACTION BEGINNING WITH THE EXAMINATION OF THE NEEDLE AFTER USE BY THE CST. UNFORTUNATELY, THE STAFF DID NOT RETAIN THE REMAINDER OF THE NEEDLE FOR AN INVESTIGATION. CAYENNE SCORPION WITH DISPOSABLE NEEDLE USED IN PATIENT. IT WAS NOTICED THAT THE TIP OF NEEDLE WAS BROKEN. DR. VISUALLY EXAMINED THE WOUND SITE WITH NO SITE OF BROKEN NEEDLE TIP. HE DIDN'T WANT TO EXPLORE INTO THE WOUND TO CAUSE FURTHER TISSUE TRAUMA. HE STATED HE WOULD TAKE AN X-RAY WHEN PATIENT RETURNS TO HIS OFFICE. DR. REFUSED TO HAVE ONE DONE WHILE PATIENT WAS IN THE OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165251 QUATTRO ACCESSORIES,ARTHROSCOPIC NBH CAYENNE MEDICAL, INC. CM-9011 59139-1

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR OTHER, X RAY TO BE OBTAINED AT POST OP VISIT PER