BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION 3724222 HOUSE IRRIGATOR 5X7FR

    MDR report key: 3071103 · Received April 22, 2013

    Report

    Report Number
    1045254-2013-00343
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 29, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    JZF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. PART # 3724225, SUCTION HOUSE IRRIGATOR 8X12FR, QTY OF 2, LOT #, SERIAL #, AND MANUFACTURE DATE UNKNOWN. (B)(4). THE QUALITY ENGINEER REVIEWED THE RETURNED INSTRUMENTS AND CONCLUDED THAT THE DAMAGE IS MOST LIKELY DUE TO EXCESSIVE FORCE FROM THE END USER. WITH THE EXCEPTION OF THE BENDS OR BREAKS DEFINED IN THE COMPLAINT, THE REMAINDER OF THE INSTRUMENTS IS INTACT AND NO VISIBLE DAMAGE IS SEEN. THE REMAINDERS OF THE INSTRUMENTS MEET SPECIFICATIONS. THE IRRIGATION PORTS ARE ATTACHED TO STAINLESS STEEL TUBING, WHICH IN ITSELF PROVIDES GOOD SUPPORT AND DOES NOT BEND EASILY. ONE IRRIGATION PORT HAD THE WELD BREAK AND IT CAME OFF THE STAINLESS STEEL TUBING. THE SECOND UNIT HAD BOTH THE WELD AND THE STAINLESS STEEL TUBING BREAK OFF, WHICH SUPPORT THE CONCLUSION OF EXCESSIVE FORCE BEING USED. RESULTS - STRESS PROBLEM (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN ISSUE WITH FOUR INSTRUMENTS AT A CADAVER LAB IN THE SAME DAY. THE HEAD OF THE IRRIGATION PORT IS BROKE OFF OF TWO OF THE INSTRUMENTS. THE OTHER TWO ARE BENT. THIS HAPPENED DURING USE OF THE INSTRUMENTS. THERE WERE NO PATIENTS INVOLVED IN THE CASE, USED IN A CADAVER LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171562 SUCTION 3724222 HOUSE IRRIGATOR 5X7FR TUBE, EAR SUCTION JZF MEDTRONIC XOMED, INC. 3724222 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1