BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VLOC 90 2/0 VL 9 V-30

    MDR report key: 3911587 · Received June 27, 2014

    Report

    Report Number
    1219930-2014-00486
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    April 23, 2014
    Report Date
    June 2, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GAM
    PMA / PMN Number
    K100257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: PELVIC LAP. ACCORDING TO THE REPORTER: TWO NEEDLE THREADS SNAPPED WHILE CLOSING PELVIC PERITONEUM LAPAROSCOPICALLY, RESULTING IN LONGER PROCEDURE TIME AND ANAESTHETIC TIME. XRAY WAS REQUIRED TO LOCATE THE 2ND NEEDLE, WHICH WAS REMOVED SAFELY. DETAILS PASSED TO THE LOCAL REP TO COMPLETE AN F+T FORM AND OBTAIN SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376267 VLOC 90 2/0 VL 9 V-30 VLOC GAM COVIDIEN, FORMERLY US SURGICAL A3H0664VVX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other