BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLADE, RAD 60, 4MM, M4 ROTAT 5/BX

    MDR report key: 3773552 · Received April 25, 2014

    Report

    Report Number
    3004209178-2014-08116
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 27, 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
    SN
    Reporter Occupation
    PHYSICIAN

    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. DIATHERMY IS THE USE OF HIGH FREQUENCY ELECTRIC CURRENT TO PRODUCE HEAT; USED TO EITHER CUT OR DESTROY TISSUE OR TO PRODUCE COAGULATION. (B)(4). PRODUCT EVALUATION: UPON ANALYSIS BY OUR QE, THE CONDITION OF THE DEVICE SHOWED CUSTOMER USE/HANDLING BASED ON THE OBVIOUS DAMAGE OBSERVED ON THE RETURNED SAMPLE. FROM VISUAL EVALUATION, THE SPIRAL WRAP OF THE MIDDLE SHAFT ASSEMBLY WAS FOUND HYPEREXTENDED AND BROKEN NEAR THE TIP WITH PORTION OF IT SEVERELY UNRAVELED. THE BREAKAGE OF THE SPIRAL WRAP ASSEMBLY CAUSED THE TIP TO DETACH / SEPARATE. THE BLADE TEETH WERE OBSERVED UNDER MAGNIFICATION AND APPEARED TO BE FREE OF DAMAGE. THE SPIRAL WRAP HYPEREXTENSION, BREAKAGE AND UNRAVELING 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 DEVICE BREAKAGE. THERE WAS NO OBVIOUS INDICATION OF CUSTOMER MISUSE / MISHANDLING OF THE PRODUCT OR ANY MANUFACTURING DEFECT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SHAVING THE TISSUE FROM THE ETHMOID, THE DEVICE EXPLODED, LEAVING THE BROKEN TIP INSIDE THE NASAL CAVITY AS HE WITHDREW THE FAULTY BLADE. NO PATIENT INJURY REPORTED BUT IT HAS CAUSED UNNECESSARY BLEEDING TO THE PATIENT. THE BROKEN PIECE OF BLADE WAS REMOVED AND A NEW BLADE WAS USED TO CONTINUE WITH THE SURGERY. MEANWHILE, THE SURGEON USED A DIATHERMY TO STOP BLEEDING BEFORE STARTING WITH THE PROCEDURE AGAIN. THERE WAS NO DELAY ENCOUNTERED. THE PATIENT IS NORMAL AND HAS BEEN DISCHARGED FROM HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251755 BLADE, RAD 60, 4MM, M4 ROTAT 5/BX BUR, EAR, NOSE AND THROAT EQJ MDT PUERTO RICO OPERATIONS CO 1884016HR H7661102

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention