BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH

    MDR report key: 6622468 · Received June 8, 2017

    Report

    Report Number
    9612501-2017-05597
    Event Type
    Malfunction
    Date Received
    June 8, 2017
    Date of Event
    April 27, 2017
    Report Date
    August 24, 2017
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    OCW
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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

    PRODUCT CODE: OCW COMMON DEVICE NAME: ENDOSCOPIC TISSUE APPROXIMATION DEVICE. EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF THE DEVICE. DEVICE HAD BIOLOGICAL RESIDUE LODGED IN ONE SIDE OF JAW. DIFFICULTY WAS EXPERIENCED IN LOADING, UNLOADING OR TOGGLING THE NEEDLES IN THE DEVICE PRIOR TO CLEANING OUT BIOLOGICAL RESIDUE. 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. REPLICATION OF THE REPORTED CONDITION MAY OCCUR WHEN BIOLOGICAL RESIDUE BUILDS UP IN THE JAWS OF THE DEVICE FROM PROLONG USE OR USE IN MORE THAN ONE PROCEDURE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE DEVICE WOULD NOT HOLD THE SUTURE. TO COMPLETE THE PROCEDURE, ANOTHER DEVICE WAS USED. NO HARM WAS CAUSED TO THE PATIENT.

    Description of Event or Problem · 1

    CAUSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407634 ENDO STITCH ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW DAVIS & GECK CARIBE LTD 173016 JM1325X

    Patients

    Seq Age Sex Outcome Treatment
    1