BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH POLYSORB 2/0 48 VIO DLU SU

    MDR report key: 2946220 · Received January 4, 2013

    Report

    Report Number
    1219930-2013-00014
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Report Date
    December 6, 2012
    Manufacturer
    COVIDIEN, FORMERLY US
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRECTOMY. ACCORDING TO THE REPORTER: NEEDLE BREAK. LIST ANY OTHER PRODUCTS USED WITH DEVICE: ENDOSTITCH LAPAROSCOPIC SUTURING DEVICE. REASON PRODUCT NOT RETURNED: PRODUCT WAS DISCARDED. NO INJURY INVOLVED. WAS THE DELAY OVER 30 MINUTES: NO. UNANTICIPATED BLOOD LOSS MORE THAN 250CC: NO. WAS THE DEVICE USED IN PT: YES. WAS THERE PT INVOLVEMENT: YES. WAS THERE PT INJURY/HAZARD: NO. FELL INTO CAVITY AND RETRIEVED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5880 ENDO STITCH POLYSORB 2/0 48 VIO DLU SU ENDOSTITCH KOG COVIDIEN, FORMERLY US UNK

    Patients

    Seq Age Sex Outcome Treatment
    1