BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 5857689 · Received August 9, 2016

    Report

    Report Number
    1045254-2016-00252
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Date of Event
    July 15, 2016
    Report Date
    July 15, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: 1845020 ¿ INDIGO OTOLOGY ANGLED ATTACHMENT; MANUFACTURED DATE ¿ SEPTEMBER 24, 2015; SERIAL NUMBER - (B)(4); LOT NUMBER - 210048767; 510K NUMBER ¿ K081475. THE HANDPIECE (1845000) AND ATTACHMENT (1845020) HAVE NOT BEEN RETURNED AT THIS TIME. A PRODUCT ANALYSIS HAS NOT BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED DATE: THE INDIGO HANDPIECE (1845000) AND ANGLED ATTACHMENT (1845020) WERE RECEIVED ON JULY 25, 2016. INDIGO HANDPIECE (1845000; SERIAL NUMBER (B)(4)): THE PRODUCT ANALYSIS INDICATES THAT THE CUSTOMER¿S COMPLAINT COULD NOT BE CONFIRMED. ONE-MINUTE PRE-REPAIR TEMPERATURE TEST RESULTS WERE AS FOLLOWS: 81 DEGREES F AT T1 AND 80 DEGREES F AT T2. THE AMBIENT TEMPERATURE WAS 76 DEGREES F. AFTER 5 MINUTES, THE TEMPERATURE AT T1 WAS 95 DEGREES F AND IT WAS 94 DEGREES F AT T2. THERE WERE NO MECHANICAL OR COSMETIC DEVIATIONS FOUND. THE HANDPIECE WAS SUCCESSFULLY TESTED TO SPECIFICATIONS. INDIGO ANGLED ATTACHMENT (1845020; SERIAL NUMBER (B)(4)): THE PRODUCT ANALYSIS INDICATES THAT THE AMBIENT TEMPERATURE WAS 75 DEGREES F. AFTER 1 MINUTE THE DEVICE WAS 96 DEGREES F AND AFTER 5 MINUTES THE DEVICE WAS 115 DEGREES F. THE BEARINGS WERE CORRODED. THE BEARINGS AND OTHER COMPONENTS WERE REPLACED. THE DEVICE WAS SUCCESSFULLY TESTED TO SPECIFICATIONS. METHOD: ACTUAL DEVICE EVALUATED (B)(4); VISUAL INSPECTION (B)(4); LABELING EVALUATION (B)(4). RESULTS: NO FAILURE DETECTED (B)(4). CONCLUSION: DEVICE REPAIRED AND RETURNED (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 "INTRAOPERATIVE, THE HANDPIECE AND/OR ANGLED ATTACHMENT GOT HOT IN LESS THAN 30 SECONDS. A REPLACEMENT HANDPIECE WAS USED TO COMPLETE THE CASE. THE PROCEDURE WAS NOT DELAYED AND THERE WAS NO PATIENT INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509250 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 210240093

    Patients

    Seq Age Sex Outcome Treatment
    1