BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUETTE MULTI-BAND MUCOSECTOMY DEVICE

    MDR report key: 3983254 · Received July 3, 2014

    Report

    Report Number
    3001845648-2014-00116
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 5, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    KOG
    PMA / PMN Number
    K050578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT REPORT MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE REPORTING PRECEDENCES ESTABLISHED FOR THIS PRODUCT FAMILY FOR 'PREMATURE BAND DEPLOYMENT'; REGARDLESS OF PATIENT OUTCOME. THE ACTUAL COMPLAINT DEVICE HAS NOT YET BEEN RETURNED TO CIRL FOR EVALUATION. AS A RESULT A DOCUMENT BASED INVESTIGATION HAS BEEN CARRIED OUT. SHOULD THE DEVICE BE RETURNED IN THE FUTURE, THE COMPLAINT FILE WILL BE UPDATED WITH THE LAB EVALUATION FINDINGS. THERE WERE NO DT-6 DEVICES OF LOT NO. C970549 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. PRIOR TO DISTRIBUTION ALL DT-6 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CAUSED THE COMPLAINT ISSUE. THIS DEVICE IS FOR ENDOSCOPIC MUCOSAL RESECTION IN THE UPPER GI TRACT. THIS DEVICE IS INTENDED FOR SINGLE USE ONLY. THE COMPLAINT WAS CONFIRMED BASED ON THE CUSTOMER'S TESTIMONY. A POSSIBLE CAUSE OF THIS COMPLAINT IS THAT THE TRIGGER CORD GOT CAUGHT OR PULLED ON IN THE ENDOSCOPE AND CAUSED THE PREMATURE DEPLOYMENT OF THE BANDS. HOWEVER AS THE DEVICE HAS NOT YET BEEN RETURNED, THE CAUSE OF THE COMPLAINT CANNOT BE CONCLUSIVELY DETERMINED. THE EVENT OCCURRED WHILE THE DEVICE WAS IN THE ENDOSCOPE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE BANDS FELL OF THE END OF THE DEVICE BEFORE THEY COULD BE DEPLOYED. THIS OCCURRED WHEN THE DEVICE WAS ON THE SCOPE BUT NOT IN THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392301 DUETTE MULTI-BAND MUCOSECTOMY DEVICE KOG ENDOSCOPE AND/OR ACCESSORIES KOG COOK IRELAND LTD C970549

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK