BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLADELESS VP 5MM W/ FIXATION

    MDR report key: 1320978 · Received February 20, 2009

    Report

    Report Number
    1219930-2009-00119
    Event Type
    Injury
    Date Received
    February 20, 2009
    Date of Event
    January 28, 2009
    Report Date
    January 28, 2009
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GCJ
    PMA / PMN Number
    K081169
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE INITIAL REPORT SENT: 02/19/2009.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP CHOLE. ACCORDING TO THE REPORTER: WHITE TIP BROKE OFF WHILE INSERTING INTO THE TROCAR. DOCTOR LOOKED FOR THE TIP AND COULD NOT FIND IT, USED ETHICON TO FINISH THE CASE. DELAY IN OR TIME WAS 10 MINUTES. NO PATIENT INJURY WAS REPORTED. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADELESS VP 5MM W/ FIXATION DISPOSABLE SURGICAL ACCESS DEVICE GCJ NORTH HAVEN - USS U8K02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other