BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLTPRT PLUS 5MM-12MM TRC W/BLTGRP

    MDR report key: 1961226 · Received December 21, 2010

    Report

    Report Number
    2647580-2010-00989
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 23, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K954108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPY. ACCORDING TO THE REPORTER: DURING THE CASE, AN INTERNAL WHITE PLASTIC PIECE STRIPPED OFF AND FELL INTO THE PATIENT'S CAVITY. THE PLASTIC PIECE WAS REMOVED AND THE DEVICE WILL BE SENT FOR EVALUATION. NO ADDITIONAL BLEEDING AND NO TISSUE DAMAGE WERE REPORTED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLTPRT PLUS 5MM-12MM TRC W/BLTGRP DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0H0326

    Patients

    Seq Age Sex Outcome Treatment
    1