BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL

    MDR report key: 4728035 · Received April 24, 2015

    Report

    Report Number
    1625507-2015-00018
    Event Type
    Malfunction
    Date Received
    April 24, 2015
    Date of Event
    March 23, 2015
    Report Date
    March 31, 2015
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ANALYSIS WAS COMPLETED ON MAY 13, 2015. THE PRODUCT ANALYSIS INDICATES THAT THE INITIAL INSPECTION OF THE DEVICE SHOWED NO SIGNIFICANT PHYSICAL DAMAGE. THE MOTOR WAS CONNECTED TO THE CONSOLE AND OPERATED AT DEFAULT SPEED WITH THE STRAIGHT AND ANGLED ATTACHMENTS. THE DRILL FUNCTIONED AND SOUNDED NORMAL WITH THE STRAIGHT ATTACHMENT (1845010). HOWEVER, THE ANGLED ATTACHMENT (1845020) SOUNDED LOUD AND THE BUR WAS DIFFICULT TO LOCK IN. THE SERVICE REPORT FOR ANGLED ATTACHMENT (1845020) INDICATES THAT THE BEARINGS AND GEARS WERE CORRODED. THE ATTACHMENT GOT TO 126.3 DEGREES F IN 5 MINUTES. THE REQUIRED COMPONENTS WERE REPLACED. RESULTS CODE: DEGRADATION PROBLEM. RESULTS: THERMAL PROBLEM. CONCLUSION: DEVICE REPAIRED AND RETURNED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: 1845000 - DRILL 1845000 INDIGO HIGH SPEED OTOLOGIC; MANUFACTURE DATE ¿ MAY 8, 2014; SERIAL NUMBER ¿ (B)(4); LOT ¿ 208309894; 510K - K081475 1845010 - ATTACHMENT 1845010 INDIGO OTOL STRAIGHT; MANUFACTURE DATE ¿ AUGUST 21, 2013; SERIAL NUMBER ¿ (B)(4); LOT ¿ 207155377; 510K - K081475. THE HANDPIECE, STRAIGHT ATTACHMENT, AND ANGLED ATTACHMENT WERE RETURNED. SERVICE AND REPAIR DID NOT RECEIVE AN O-RING WITH THE HANDPIECE OR THE ATTACHMENTS. 1845020: THE PRE-REPAIR TEMPERATURE TEST RESULTS FOR THE ANGLED ATTACHMENT WERE AS FOLLOWS: 198 DEGREES F AT THE NOSE, 112 DEGREES F AT THE MIDDLE, AND 99 DEGREES F AT THE REAR. SERVICE AND REPAIR WAS ABLE TO VERIFY THAT THE ANGLED ATTACHMENT DID GET HOT. THE ANGLED ATTACHMENT HAS BEEN FORWARDED TO MEDTRONIC PSS FOR ANALYSIS AND REPAIR. 1845000: THE SERVICE REPORT INDICATES THAT THE CUSTOMER'S COMPLAINT COULD NOT BE VERIFIED. THE PRE-REPAIR TEMPERATURE RESULTS WERE AS FOLLOWS: 81 DEGREES F AT THE NOSE, 79 DEGREES F AT THE MIDDLE, AND 78 DEGREES F AT THE REAR. THERE WAS NO FAULT FOUND WITH THE HANDPIECE. IT WAS CLEANED, TESTED, AND PASSED TO MANUFACTURING SPECIFICATIONS. 1845010: THE SERVICE REPORT INDICATES THAT THE CUSTOMER'S COMPLAINT COULD NOT BE VERIFIED. THE PRE-REPAIR TEMPERATURE RESULTS WERE AS FOLLOWS: 76 DEGREES F AT THE NOSE, 74 DEGREES F AT THE MIDDLE, AND 73 DEGREES F AT THE REAR. THERE WAS NO FAULT FOUND WITH THE HANDPIECE ATTACHMENT. IT WAS CLEANED, TESTED, AND PASSED TO MANUFACTURING SPECIFICATIONS. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    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 WAS GETTING HOT. THEY HAD TO USE A DAMP TOWEL TO WRAP AROUND THE DRILL WHILE BEING USED. PART WAY THROUGH THE PROCEDURE, THE DOCTOR WAS FRUSTRATED AND SWITCHED OUT THE HANDPIECE. IT WAS ALSO REPORTED THAT AN O-RING FELL OUT OF THE DRILL WHEN A DRILL BIT (BUR/ATTACHMENT) WAS BEING SWITCHED. THE HANDPIECE, STRAIGHT ATTACHMENT, AND ANGLED ATTACHMENT WERE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274383 IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MDT POWERED SURGICAL SOLUTIONS 1845020 207305240

    Patients

    Seq Age Sex Outcome Treatment
    1