BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE 1884002 5PK SERRATED 4MM

    MDR report key: 3673112 · Received March 11, 2014

    Report

    Report Number
    3004209178-2014-04241
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    February 6, 2014
    Report Date
    February 16, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.(B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. AS RECEIVED CONDITION: RECEIVED 1 SAMPLE(S), PART NUMBER 1884002, FROM LOT NUMBER H8742289. ANALYSIS RESULTS: EQUIPMENT USED: MICROSCOPE (ZEISS STEMI 2000C BETWEEN 0,65 TO 5,0 MAGNIFICATION SETTINGS). OBSERVATIONS: WHEN COMPARED TO THE ASSEMBLY DRAWING (B)(4) AND (B)(4): THERE WAS A GOUGE IN THE INNER AND OUTER MOUTH OPENING AT THE TIP WHICH WOULD HAVE RESULTED IN THE REPORTED MALFUNCTION. WHEN VIEWED UNDER MAGNIFICATION, THERE WAS A SMALLER SECONDARY GOUGE DISTAL TO THE FIRST NEAR THE LAST TOOTH ON THE SAME SIDE. THERE WERE ABRASIONS NEAR THE LARGER GOUGE. THE INFORMATION INDICATES THE DEVICE CAME IN CONTACT WITH ANOTHER DEVICE [POTENTIALLY A STYLET] WHILE MOVING IN A COUNTERCLOCKWISE DIRECTION, WHICH CAUSED THE INNER BLADE TO LIFT UP AND CATCH THE OUTER MOUTH OPENING; THE ABRASIONS MOST LIKELY OCCURRED WHILE TRYING TO DISLODGE THE OTHER DEVICE FROM THE TIP. BASED ON THE PRODUCT ANALYSIS FINDINGS THE REPORTED COMPLAINT WAS CONFIRMED WITH THE ROOT CAUSE LIKELY THE RESULT OF MISHANDLING OF THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ¿THIS BUR GOT BROKEN DURING THE OPERATION.¿ THERE WAS NO REPORT OF PATIENT IMPACT OR INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144482 BLADE 1884002 5PK SERRATED 4MM BUR, EAR, NOSE AND THROAT EQJ MDT PUERTO RICO OPERATIONS CO 1884002 H8742289

    Patients

    Seq Age Sex Outcome Treatment
    1