BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADELESS VP 11MM ST W/FIXATION

    MDR report key: 3062604 · Received March 18, 2013

    Report

    Report Number
    1219930-2013-00185
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Report Date
    February 25, 2013
    Manufacturer
    COVIDIEN FORMERLY US SUR
    Product Code
    GCJ
    PMA / PMN Number
    K081169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HYSTERECTOMY. ACCORDING TO THE REPORTER: PROFESSOR HUH USED A VERSAPORT BLADELESS TROCAR 11MM. WHEN HE INSERTED THE TROCAR HE HEARD SOME CRACKING SOUNDS BUT HE DID NOT SEE ANYTHING BROKEN WITH THE CANNULA. AFTER HE FINISHED WITH HIS PROCEDURE, HE REALIZED THE TIP PART OF THE OBTURATOR AND DILATING FINS HAD BEEN BROKEN. TO FIND THE BROKEN PIECES, HE RE-OPENED THE INCISION SITE AND FOUND THE PIECES STUCK IN THE SUB-CUTANEOUS LAYER OF THE ABDOMINAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111630 BLADELESS VP 11MM ST W/FIXATION DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN FORMERLY US SUR

    Patients

    Seq Age Sex Outcome Treatment
    1