BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED DIAMOND DCR BUR,2.5MM,HI-SPD 3/BX

    MDR report key: 2460699 · Received February 17, 2012

    Report

    Report Number
    1045254-2012-00022
    Event Type
    Malfunction
    Date Received
    February 17, 2012
    Date of Event
    December 14, 2011
    Report Date
    January 24, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. THE INFORMATION REASONABLY SUGGESTS THAT THE DEVICE IN QUESTION HAS MALFUNCTIONED AS DEFINED BY THE FDA AND INDICATES THAT THIS A PRODUCT PROBLEM. THE PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THIS PRODUCT'S COMPLAINT HISTORY SHOWS THAT PATIENT INJURY HAS PREVIOUSLY OCCURRED FROM THE ALLEGED COMPLAINT MALFUNCTION MODALITY, HOWEVER, THIS MALFUNCTION IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY BASED ON THE FDA'S DEFINITION OF "LIKELY" IF IT WERE TO RECUR. THE PRODUCT WAS RETURNED IN ORIGINAL POUCH AND LABELING IDENTIFIED THE SAMPLE AS A BUR. THE TIP WAS COMPLETELY BROKEN OFF AT THE LAST SPIRAL WRAP FURTHEST FROM THE DISTAL TIP. THE BREAK WAS A TYPICAL EXTENDED SPIRAL BREAK, INDICATIVE OF SPIRAL-WRAP FAILURE AFTER ELONGATION AND CROSS-SECTION AREA REDUCTION OF THE WRAP. A POWERED HANDPIECE FOR FUNCTIONAL ENDOSCOPIC SINUS SURGERY USES A VARIETY OF DISPOSABLE BLADES AND BURS. THE INDICATIONS FOR USE OF BURS AND BLADES IN SINUS INDICATIONS INCLUDE: SEPTOPLASTY, REMOVAL OF SEPTAL SPURS, POLYPECTOMY, ANTROSTOMY, ETHMOIDECTOMY/SPHENOETHMOIDECTOMY, FRONTAL SINUS TREPHINATION AND IRRIGATION, MAXILLARY SINUS POLYPECTOMY, CIRCUMFERENTIAL MAXILLARY ANTROSTOMY, AND CHOANAL ATRESIA. IT IS THE RESPONSIBILITY OF THE SURGICAL TEAM TO SELECT THE APPROPRIATE INSTRUMENT FOR EACH CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SINUS SURGERY, THE DOCTOR FOUND THE INNER DRILL WAS BROKEN. THE PATIENT WAS FINE POST SURGERY. NO CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURVED DIAMOND DCR BUR,2.5MM,HI-SPD 3/BX BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC. 1882569HS H7817697

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR