BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH

    MDR report key: 6493167 · Received April 14, 2017

    Report

    Report Number
    9612501-2017-05345
    Event Type
    Malfunction
    Date Received
    April 14, 2017
    Date of Event
    March 22, 2017
    Report Date
    August 23, 2017
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    OCW
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRODUCT ANALYSIS: POST MARKET VIGILANCE (PMV) RECEIVED TWO DEVICES. THE VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED: WITNESS MARKS FROM THE NEEDLE TIP IMPACTING THE BEVELED WALL WERE OBSERVED FOR BOTH DEVICES. NO SHEARING OF THE TOGGLE SWITCHES WAS OBSERVED FOR ANY OF THE DEVICES UNDER MICROSCOPIC INSPECTION. PMV PERFORMED FUNCTIONAL TESTING ON THE DEVICES. DEVICES WERE LOADED WITH A NEEDLE FROM THE POST MARKETING VIGILANCE (PMV) INVENTORY AND APPLIED TO TEST MEDIA. PRESSURE WAS EXERTED ON THE NEEDLE IN ALL DIRECTIONS FROM BOTH SIDES OF THE JAWS DURING THIS TEST IN AN EFFORT TO SIMULATE CLINICAL CONDITIONS. DEVICE ONE WAS FOUND TO NOT FUNCTION PROPERLY AS NEEDLE DISENGAGED WHILE BEING TOGGLED IN MEDIA AND BEING TOGGLE OUTSIDE OF MEDIA. NO DIFFICULTY WAS EXPERIENCED IN LOADING AND UNLOADING THE NEEDLE IN DEVICE TWO. DIFFICULTY WAS EXPERIENCED IN TOGGLING THE NEEDLE IN DEVICE ONE. DEVICES WILL BE FORWARDED TO ENGINEERING FOR FURTHER ANALYSIS AS DEVICE TWO HAD JAWS THAT BECAME MISALIGNED AND NEEDLE WOULD DISENGAGE FROM THE DEVICE WHILE TOGGLING. 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

    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.

    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

    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

    DURING PARAESOPHAGEAL HERNIA REPAIR THE DEVICE WAS DIFFICULT TO LOAD AND THE NEEDLE DROPPED ON THE FIRST PASS. USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE, NO HARM TO PATIENT. PATIENT STATUS: ALIVE; NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276463 ENDO STITCH ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW DAVIS & GECK CARIBE LTD 173016 J6L2278X

    Patients

    Seq Age Sex Outcome Treatment
    1