BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERC-DLG CONVENIENCE PACK

    MDR report key: 677229 · Received February 10, 2006

    Report

    Report Number
    2951580-2006-00003
    Event Type
    Other
    Date Received
    February 10, 2006
    Date of Event
    January 6, 2006
    Report Date
    February 8, 2006
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A NUCLEOPLASTY PROCEDURE OF THE L2 DISC, THE CRAWFORD NEEDLE TIP BROKE AND REMAINED IN THE PATIENT'S DISC. A SECOND INCISION WAS MADE AND THE FRAGMENT, 3 INCHES IN LENGTH, WAS REMOVED BY THE PHYSICIAN. A SECOND NEEDLE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERC-DLG CONVENIENCE PACK ELECTROSURGICAL DEVICE GEI ARTHROCARE CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other