BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURVED SINUS BURS

    MDR report key: 4298722 · Received December 4, 2014

    Report

    Report Number
    3004209178-2014-22624
    Event Type
    Injury
    Date Received
    December 4, 2014
    Date of Event
    November 12, 2014
    Report Date
    November 12, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1898200T, MICRODEBRIDER IGS M4, MANUFACTURE DATE: UNKNOWN; SERIAL NUMBER: UNKNOWN, 510K NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS EVALUATED BY THE QUALITY ENGINEERING TEAM. RECEIVED SAMPLE WITH ORIGINAL OPENED POUCH AND LABELS. THE CONDITION OF THE DEVICE SHOWED CUSTOMER USE AS THERE WAS PRESENCE OF CONTAMINANTS ON THE BUR HEAD. OBSERVATIONS: FROM VISUAL EVALUATION, THE SPIRAL WRAP WAS FOUND BROKEN NEAR THE TIP. THE SPIRAL WRAP HYPEREXTENSION, UNRAVELING, OR BREAKING IS INDICATIVE OF POSSIBLE PROCEDURAL / ANATOMICAL / OPERATIONAL FACTORS ENCOUNTERED BY THE CUSTOMER DURING PROCEDURE WHICH MAY HAVE LED TO THE FAILURE OBSERVED ON THE DEVICE. THESE FACTORS INCLUDE AND ARE NOT LIMITED TO DIFFICULT ANATOMICAL LOCATION, HARD BONE/TISSUE STRUCTURE. THESE FACTORS CAN CAUSE THE CUSTOMER TO EXERT PRESSURE, MANIPULATE AND/OR MANEUVER THE DEVICE IN A MANNER THAT MAY LEAD TO HYPEREXTENSION OR BREAKAGE OF THE SPIRAL WRAP ASSEMBLY. BASED ON THE ABOVE OBSERVATIONS THE MOST LIKELY UNDERLYING CAUSE IS RELATED WITH 'OPERATIONAL CONTEXT' AS IT IS POSSIBLE THAT CUSTOMER MANEUVERING / MANIPULATION OF THE DEVICE DUE TO POSSIBLE PROCEDURAL / ANATOMICAL / OPERATIONAL FACTORS ENCOUNTERED DURING THE PROCEDURE MAY HAVE LED TO THE FAILURE EVENT. METHODS ¿ ACTUAL DEVICE EVALUATED; VISUAL INSPECTION. RESULTS ¿ OPERATIONAL PROBLEM; STRESS PROBLEM. CONCLUSIONS ¿ OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HIGH SPEED BUR WAS BROKEN. DURING A LOTHROP PROCEDURE, THE BUR WAS TURNING IN THE HANDPIECE WHICH CAUSED THE DOCTOR TO RE-CALIBRATE IT MORE OFTEN. THEN THE BUR BROKE OFF IN THE PATIENT'S NOSE. USING FORCEPS, THE BROKEN TIP WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT¿S NOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785217 CURVED SINUS BURS BUR, EAR, NOSE AND THROAT EQJ MDT PUERTO RICO OPERATIONS CO 1883672HS H8978312

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention