BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VERSASTEP

    MDR report key: 4917902 · Received July 16, 2015

    Report

    Report Number
    1219930-2015-00550
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    April 21, 2015
    Report Date
    July 9, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: BARIATRIC PROCEDURE. ACCORDING TO THE REPORTER: SIZE 15MM COVIDIEN TROCAR USED IN BARIATRIC LAPAROSCOPIC SURGERY. EDGE OF MESH AND END OF PORT BROKE DURING SURGERY. MESH PIECE WAS RETRIEVED. END OF PORT COULD NOT BE LOCATED IN THE PATIENT. EXPANDING MESH WHICH SURROUNDING THE TROCAR ITSELF. THERE WAS NO UNANTICIPATED TISSUE LOSS. PORT FRAGMENTS IN SUBCUTANEOUS TISSUE AWAITING WEIGHT LOSS TO RECOVER FRAGMENTS. TISSUE IRRITATION IN THE TRACT. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500CC OR MORE. SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM. PROLONGED VENTILATION POSTOP. DISCHARGED HOME, UNDER CONTINUAL MONITORING FOR COMPLICATIONS.? YES. A) WAS ANY ADVERSE EVENT REPORTED AS A RESULT OF ANY DELAY IN SURGERY? (I.E. AN EXTENSION OF THE HOSPITAL STAY, INFECTION, ETC.?) YES. PROLONGED VENTILATION POSTOP. 9. WHAT IS THE CURRENT STATUS OF THE PATIENT? DISCHARGED HOME, UNDER CONTINUAL MONITORING FOR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463096 UNKNOWN VERSASTEP DISPOSABLE SURGICAL ACCESS DEVICE GAG COVIDIEN, FORMERLY US SURGICAL A DIVISON UNKNOWN VERSAST

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R