BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH

    MDR report key: 6672716 · Received June 28, 2017

    Report

    Report Number
    9612501-2017-05689
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    March 1, 2017
    Report Date
    August 24, 2017
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    OCW
    UDI-DI
    20884521100005
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF TWO DEVICES. DEVICE ONE HAD BENT BLADES. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES; THEREFORE, A DEVICE HISTORY RECORD WILL NOT BE PERFORMED. REPLICATION OF THE BENT BLADE INDICATES THAT THE INSTRUMENT MAY HAVE BEEN EXPOSED TO AN EXTERNAL FORCE WHICH BENT THE EXPOSED METAL BARS. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. CORRECTION: PRODUCT CODE: OCW; COMMON DEVICE NAME: ENDOSCOPIC TISSUE APPROXIMATION DEVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING LAPAROSCOPIC ESOPHAGECTOMY,THE DEVICE HAD DIFFICULTIES IN TOGGLING/LOADING/UNLOADING, NEEDLE ALSO FELL INTO THE PATIENT¿S CAVITY (NO INFORMATION WAS PROVIDED REGARDING THE NEEDLE¿S STATUS). A NEW DEVICE WAS USED IN ORDER TO COMPLETE THE CASE. PATIENT STATUS : UNKNOWN.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, PER ADDITIONAL INFORMATION RECEIVED NO NEEDLE FELL INTO THE PATIENTS CAVITY .THE PATIENTS STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455362 ENDO STITCH ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW DAVIS & GECK CARIBE LTD 173016 J6M1898X 20884521100005

    Patients

    Seq Age Sex Outcome Treatment
    1