BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIWAND*II 5MM SUC/IRR W/CAUT/SPATULA

    MDR report key: 5983109 · Received September 28, 2016

    Report

    Report Number
    2647580-2016-00766
    Event Type
    Malfunction
    Date Received
    September 28, 2016
    Date of Event
    August 31, 2016
    Report Date
    September 2, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GEI
    PMA / PMN Number
    K961771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED ONE DEVICE BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. THE VISUAL INSPECTION OF THE DEVICE NOTED THAT THE COLLAR WAS DAMAGED ON THE INSTRUMENT; THE COLLAR WAS ATTACHED TO THE DEVICE BUT A PLASTIC TAB WAS BROKEN. DURING A FUNCTIONAL EVALUATION, THE INSTRUMENT WAS TESTED FOR ELECTRICAL CONTINUITY AND PROPER SUCTION AND IRRIGATION FUNCTION WITH ACCEPTABLE RESULTS. THE INSTRUMENT ALSO PASSED TWO AIR LEAK TESTS. REPLICATION OF THE OBSERVED DAMAGE MAY OCCUR IF EXCESS FORCE IS USED WHEN THE COLLAR IS PUSHED FORWARD TO COVER THE L-HOOK. BASED ON THE PRODUCT ANALYSIS, THE FAILURE WAS CONFIRMED TO BE ATTRIBUTED TO THE REPORTED EVENT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING PREPARATION FOR A PROCEDURE, THE WHITE PART WAS DISENGAGED FROM THE CONNECTION OF THE SHEATH OUT-OF-PACKAGE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635862 SURGIWAND*II 5MM SUC/IRR W/CAUT/SPATULA ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN, FORMERLY USSC PUERTO RICO INC 178099 P6E0318X

    Patients

    Seq Age Sex Outcome Treatment
    1