BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6158690 · Received December 9, 2016

    Report

    Report Number
    9612501-2016-01049
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 15, 2016
    Report Date
    May 15, 2017
    Manufacturer
    COVIDIEN
    Product Code
    OCW
    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).

    Additional Manufacturer Narrative · 1

    POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE EVENT REPORT ALLEGES THE PRODUCT WAS USED IN A SURGICAL PROCEDURE. VISUAL FUNCTIONAL INDICATED NO ABNORMALITIES. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A ROUX-EN-Y, WHEN USING THE DEVICE, THE NEEDLE FELL OFF. THE SURGEON WAS EVENTUALLY ABLE TO USE ANOTHER DEVICE TO FINISH THE CASE. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    THERE WAS A DELAY IN SURGICAL TIME OF OVER 30 MINUTES. THE DELAY DID NOT AFFECT THE PATIENT. NO DEVICE FRAGMENT FELL INTO THE PATIENT CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813806 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN 173016 J6C0998X

    Patients

    Seq Age Sex Outcome Treatment
    1