BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VLOC 180 ESTITCH ABS 2 0 8 LP

    MDR report key: 3851306 · Received March 26, 2014

    Report

    Report Number
    1219930-2014-00246
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    February 26, 2014
    Report Date
    February 27, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY US
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAVH. ACCORDING TO THE REPORTER: DURING SUTURING OF THE VAGINAL CUFF, THE VLOC SUTURE ON THE ENDOSTITCH BROKE AT THE COUPLING THAT JOINS IT TO THE SHORT STRAND OF SUTURE ATTACHED TO NEEDLE. THERE WAS NO PATIENT INJURY. THE CASE WAS NOT EXTENDED MORE THAN THIRTY MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176629 VLOC 180 ESTITCH ABS 2 0 8 LP DISPOSABLE SUTURING DEVICE KOG COVIDIEN LP, FORMERLY US N3M1357X

    Patients

    Seq Age Sex Outcome Treatment
    1