BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDO-CLIP/STITCH SURGIDAC O ES-9

    MDR report key: 17184761 · Received June 21, 2023

    Report

    Report Number
    MW5118685
    Event Type
    Other
    Date Received
    June 21, 2023
    Date of Event
    June 15, 2023
    Report Date
    June 15, 2023
    Manufacturer
    COVIDIEN
    Product Code
    OCW
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SURGIDAC-ENDOCLIP BROKE OFF A PIECE IN PT. DURING PROCEDURE; "SURGEON AND STAFF NOTED A SMALL PIECE MISSING OFF UPPER RIGHT SIDE OF SURGIDAC O. STERILE FIELD AND TABLE SEARCHED . XRAY TAKEN SMALL OBJECT NOTED ON XRAY. CONFIRMED BY RADIOLOGIST (DR. (B)(6) COVIDIEN MEDTRONIC REP - (B)(6), NOTIFIED 06/16/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758573 ENDO-CLIP/STITCH SURGIDAC O ES-9 ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN 173024 J2K0330Y

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Other