BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIZE 0 8 PBT RELOAD WITH LOOP

    MDR report key: 4008887 · Received June 27, 2014

    Report

    Report Number
    1219930-2014-00490
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 4, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE V-LOC ENDOSTITCH RELOAD NEEDLE DID NOT PASS FROM ONE SITE TO THE OTHER SIDE OF THE ENDOSTITCH HAND INSTRUMENT. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO IRREVERSIBLE TISSUE DAMAGE AS A RESULT OF THIS PROBLEM. THERE WAS NO UNANTICIPATED EXTENSION OF THE INCISION BY MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500CC'S OR MORE. THE SURGICAL TIME WAS NOT DELAYED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM. A DEVICE FRAGMENT OR COMPONENT DID NOT FALL INTO THE PATIENT'S CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376655 SIZE 0 8 PBT RELOAD WITH LOOP DISPOSABLE SUTURING DEVICE RELOAD KOG COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES N2M0248UX

    Patients

    Seq Age Sex Outcome Treatment
    1