BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6158823 · Received December 9, 2016

    Report

    Report Number
    9612501-2016-01050
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Report Date
    November 15, 2016
    Manufacturer
    COVIDIEN
    Product Code
    OCW
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HAS BEEN RECEIVED BUT EVALUATION NOT YET BEGUN. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE WAS LOCKING UP. THE DEVICE WAS JAMMING. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814592 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN 173016

    Patients

    Seq Age Sex Outcome Treatment
    1