BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XOMED® INSTRUMENTS

    MDR report key: 4385305 · Received January 6, 2015

    Report

    Report Number
    9680837-2015-00003
    Event Type
    Malfunction
    Date Received
    January 6, 2015
    Date of Event
    November 30, 2014
    Report Date
    December 14, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    JYT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE HAS BEEN RECEIVED AND PENDING PRODUCT ANALYSIS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS WAS COMPLETED BY THE QUALITY ENGINEERING TEAM. AS RECEIVED CONDITION: RECEIVED 1 SAMPLE(S), PART NUMBER 3722058. EQUIPMENT USED: MICROSCOPE (ZEISS STEMI 2000C BETWEEN 0,65 TO 5,0 MAGNIFICATION SETTINGS). OBSERVATIONS: WHEN VIEWED UNDER MAGNIFICATION, THE TIP WAS BENT WHICH WOULD HAVE RESULTED IN THE REPORTED MALFUNCTION. MANUFACTURING AND MISHANDLING CANNOT BE RULED OUT AS POTENTIAL CAUSES. BASED ON THE OBSERVATIONS THERE ARE MULTIPLE POTENTIAL CAUSES AND EACH IS EQUALLY LIKELY. THERE WAS NO ADDITIONAL DEFINITIVE EVIDENCE TO INDICATE A ROOT CAUSE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ¿MALFUNCTION OF LOCKING SYSTEM: BROKEN TIP . IT IS THE FIRST TIME TO USE AFTER PURCHASING.¿ FOLLOW-UP COMMUNICATIONS OBTAINED ADDITIONAL INFORMATION. THE TIP BREAK RESULTED IN A FRAGMENT. THERE WAS NO PATIENT IMPACT OR INJURY. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6220 XOMED® INSTRUMENTS PICK, MICROSURGICAL EAR JYT XOMED MICROFRANCE MFG 3722058 120704

    Patients

    Seq Age Sex Outcome Treatment
    1