BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC MIDEX REX LEGAND DRILL

    MDR report key: 557792 · Received November 11, 2004

    Report

    Report Number
    557792
    Event Type
    Malfunction
    Date Received
    November 11, 2004
    Date of Event
    September 16, 2004
    Report Date
    November 11, 2004
    Manufacturer
    MEDTRONIC MIDA REX
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON EXAMINATION, GREEN HOSE HAD LARGE TEAR NEAR THE HANDPIECE. WALL OUTLET PRESSURE WAS SET AT 150 PSI, PER SQUARE INCH OF PRESSURE. STAFF WITHIN IMMEDIATE VICINITY OF THIS EVENT EXPERIENCED DIMINISHED HEARING AT THE TIME, WHICH HAS SINCE RETURNED TO NORMAL. FURTHER FOLLOW UP REVEALS THAT THE HOSES HAD RECENTLY BEEN UPGRADED (COMPANY UPGRADE BEGAN APPROXIMATELY ONE MONTH PRIOR TO FACILITY'S EVENT) BY MIDAS REX. THIS IS NOT SOMETHING FACILITY INITIATED - THE COMPANY BEGAN TO CHANGE OUT THE PRODUCT TO THE NEWLY DEVELOPED "SOFTER MORE FLEXIBLE" HOSE. THESE NEW HOSES STARTED COMING IN AND OR EQUIPMENT STAFF WERE TOLD BY MIDAS REX SALES REPRESENTATIVES TO CHANGE OVER IMMEDIATELY. THE FIRST DAY, STAFF TOOK A BRAND NEW HOSE OUT OF THE MIDAS REX BOX, IT WAS FLASH STERILIZED FOR THE CASE IN QUESTION, WAS HOOKED UP AND PROMPTLY EXPLODED DURING USE. STAFF ASSUMED THIS WAS AN ISOLATED EVENT, REPORTED TO BOTH SALES REPRESENTATIVE (FACILITY WAS TOLD THAT THIS WAS THE FIRST REPORTED SUCH AN EVENT) AND THE FDA, BUT THE OR STAFF DID BEGIN TO USE THESE NEW HOSES ROUTINELY. IT WAS REVEALED THAT OTHER FACILITIES WERE HAVING THE SAME PROBLEM OF BURSTING HOSES. THE EQUIPMENT STAFF IMMEDIATELY CONFRONTED THE MIDAS REX SALES REPRESENTATIVE, WHO THEN ACKNOWLEDGED THE SAME ISSUE AT OTHER HOSPITALS. THE SALES REPRESENTATIVE THEN TOLD THE FACILITY THAT ANOTHER NEW HOSE PRODUCT "HAS BEEN DEVELOPED" AND WILL BE COMING "BUT ITS NOT READY FOR DISTRIBUTION." AT THAT TIME, THE FACILITY MADE A UNILATERAL DECISION AND SWITCHED BACK TO THE OLDER DESIGNED HOSES FOR FACILITY'S 12 DRILLS. MORE RECENTLY, THE FACILITY RECEIVED AN UNDATED LETTER FROM MIDAS REX "IMPORTANT SAFETY INFORMATION" WHICH DETAILS THE POTENTIAL RISK OF A "BURSTING HOSE", WHICH ACCORDING TO FACILITY'S SALES REPRESENTATIVE, THE LETTER WAS PENNED AFTER RECEIVING SEVERAL USER COMPLAINTS. THE LETTER EXPLAINS HOW TO "MITIGATE RISK" BUT ACCORDING TO FACILITY'S OR CLINICIANS IS UNACCEPTABLE. THE CLINICIANS EXPLAINED THAT THEY MUST SECURE THE HOSE TO THE FIELD TO PREVENT CONTAMINATION. ACCORDING TO THE SAFETY INFORMATION LETTER, IF THE HOSE IS NOT SECURED PERFECTLY, THIS CAN CAUSE THE HOSE PRESSURE TO BUILD AND THE HOSE MAY BURST "STARTLING THE SURGEON, WHICH MAY INADVERTENTLY DAMAGE TISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MIDEX REX LEGAND DRILL DRILL HTW MEDTRONIC MIDA REX * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *