BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSASTEP 11 MM SGLUSE DIL/CANN RAD EXPSL

    MDR report key: 3911563 · Received June 27, 2014

    Report

    Report Number
    9612501-2014-00202
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 13, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    PMA / PMN Number
    K012539
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: OOPHOROCYSTECTOMY. ACCORDING TO THE REPORTER: AFTER THE SECOND TROCAR WAS INSERTED INTO THE PT, UPON SETTING THE LAPAROSCOPE THROUGH IT, A DOCTOR CONFIRMED A PART OF OUTER SLEEVE WAS BROKEN THROUGH THE MONITOR. THE CASE WAS SUSPENDED TO DETECT THAT BROKEN PART. EVEN BY USING CT SCANNING AND SONOGRAPHY, NOTHING WAS CONFIRMED INSIDE OF LAPAROSCOPE AND IN THE CAVITY. PERFORMING MINILAPAROTOMY BUT STILL NOTHING WAS FOUND. OBSERVED A PART OF THE EXPANDABLE DOUBLE SLEEVE WAS BROKEN. EXPANDING THE SURGICAL INCISION AROUND THE SECOND PORT BY CUTTING ABOUT 1 CM, FOUND THERE REMAINED TO BE A PART LEFT UNDER THE SKIN. CONFIRMED THIS ONE WAS A MISSING PART OF THE CONCERNING PRODUCT. THEN CUTTING THE SURGICAL INCISION, THEN A BROKEN PART AND ECHO. OPERATING TIME EXTENDED: MORE THAN 30 MIN. TISSUE DAMAGE: YES. PIECES FELL INTO THE CAVITY AND COULD BE RETRIEVED. OOZING BLEEDING. PT CURRENTLY UNDER FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376256 VERSASTEP 11 MM SGLUSE DIL/CANN RAD EXPSL DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention