BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6001078 · Received October 5, 2016

    Report

    Report Number
    9612501-2016-00712
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Report Date
    September 12, 2016
    Manufacturer
    COVIDIEN
    Product Code
    OCW
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4). EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) RECEIVED ONE ENDO STITCH SUTURING DEVICE. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. NO NEEDLE WAS RETURNED WITH THE INSTRUMENT. NO WITNESS MARKS ON THE BEVEL WALL WERE OBSERVED, INDICATING PROPER ALIGNMENT OF THE JAWS. NO SHEERING ON THE TOGGLE SWITCHES WAS NOTED. THE INSTRUMENT WAS LOADED WITH A PMV REPRESENTATIVE NEEDLE AND APPLIED TO TEST MEDIA. PRESSURE WAS EXERTED ON THE NEEDLE IN ALL DIRECTIONS FROM BOTH SIDES OF THE JAWS. THE INSTRUMENT WAS FOUND TO FUNCTION PROPERLY AND THE NEEDLE REMAINED INTACT. NO DIFFICULTY WAS EXPERIENCED IN LOADING, UNLOADING, OR TOGGLING THE NEEDLE. THE FILE WAS ALSO CONCLUDED TO BE COULD NOT BE RELIABLY DETERMINED. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND REASSESSED AT THAT TIME.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE USER EXPERIENCED ISSUES WITH LOADING THE SUTURE AND THEN THE SUTURE DROPPED FROM THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650503 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN 173016 J6E2470X

    Patients

    Seq Age Sex Outcome Treatment
    1