BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VLOC 90 3/0 VL V-20

    MDR report key: 2950505 · Received February 5, 2013

    Report

    Report Number
    1219930-2013-00068
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GAM
    PMA / PMN Number
    K100257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE NEEDLE LOOSENED FROM STRAND ON V-LOC WHEN IT WAS GOING TO BE PUT DOWN THE TROCAR. THEY NOTICED ON THE SCREEN WHEN THEY SEE THE V-LOC INSIDE THE PATIENT THAT THERE IS NO NEEDLE. DUE TO THAT, THE NEEDLE WHICH LOOSENED FROM STRAND FIRST COULD NOT BE FOUND. THEY HAD TO BRING X-RAY MACHINE INTO THE OPERATING ROOM AND X-RAY THE PATIENT. THEY WERE AFRAID THAT THE NEEDLE WAS INSIDE THE PATIENT. FINALLY THEY FOUND THE NEEDLE OUTSIDE THE PATIENT. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. NO HARM TO PATIENT. THIS WAS THE SECOND TIME THIS HAPPENED (BOTH FROM THE SAME BATCH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48969 VLOC 90 3/0 VL V-20 VLOC GAM COVIDIEN, FORMERLY US SURGICAL A2C0451X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other