BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUETTE MULTI-BAND MUCOSECTOMY DEVICE

    MDR report key: 4321981 · Received November 27, 2014

    Report

    Report Number
    3001845648-2014-00285
    Event Type
    Malfunction
    Date Received
    November 27, 2014
    Date of Event
    October 30, 2014
    Report Date
    October 30, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    KOG
    PMA / PMN Number
    K050578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INCIDENTS MEETS REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE REPORTING PRECEDENCE ESTABLISHED FOR THIS PRODUCT FAMILY FOR 'PREMATURE BAND DEPLOYMENT'; REGARDLESS OF PT OUTCOME. THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "THE DUETTE MULTI-BAND MUCOSECTOMY DEVICE FIRED 2 BANDS INSTEAD OF 1. THE EXTRA BAND MADE THE RESECTION MORE DIFFICULT AS IT WAS IN THE WAY." THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED TO COOK IRELAND FOR EVAL. AS THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVAL, THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. THE COMPLAINT WAS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY. PRIOR TO DISTRIBUTION, ALL DT-6 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. THERE IS ALSO A VISUAL INSPECTION OF THE PRODUCT AND PACKAGING COMPLETED AT PACKAGING, PACKAGING QC, POST STERILE QC IN CIRL. A REVIEW OF THE MFR RECORDS FOR DT-6 DEVICES OF LOT NUMBER C972363 REVEALED NO ISSUE ASSOCIATED WITH THIS COMPLAINT. THERE HAVE BEEN NO REPORTED ADVERSE EFFECTS TO THE PT AS A RESULT OF THIS OCCURRENCE. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    THE DUETTE MULTI-BAND MUCOSECTOMY DEVICE FIRED 2 BANDS INSTEAD OF 1. THE EXTRA BAND MADE THE RESECTION MORE DIFFICULT AS IT WAS IN THE WAY. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770752 DUETTE MULTI-BAND MUCOSECTOMY DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG COOK IRELAND LTD C972363

    Patients

    Seq Age Sex Outcome Treatment
    1