BEUDAMED
    FDA Adverse Event Death Summary report: N

    FOOT CONTROL F/PNEUMATIC MOTORS

    MDR report key: 8916537 · Received August 21, 2019

    Report

    Report Number
    9610612-2019-00472
    Event Type
    Death
    Date Received
    August 21, 2019
    Date of Event
    January 23, 2019
    Report Date
    August 21, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    HBB
    PMA / PMN Number
    K980686
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE DID RECEIVE APPROVAL FOR DISASSEMBLY/INVESTIGATION OF THE PROVIDED PRODUCTS. MANUFACTURING SITE EVALUATION: INVESTIGATION - WE DID RECEIVE THE PRODUCTS. THE INVESTIGATION WAS CARRIED OUT BY AESCULAP TECHNICAL SERVICES (ATS). FAILURE DESCRIPTION - OPTICALLY, THE PRODUCTS ARE IN A USED CONDITION. THE AIR HOSE IS IN A USED CONDITION. A FUNCTIONAL TEST COULD NOT BE CARRIED OUT DUE TO ITS DEFECT. THE CLAMPING RING ON THE HAND PIECE SIDE IS NOT IN THE PROPER POSITION. AFTER DISASSEMBLY OF THE HAND PIECE SIDE, IT CAN BE FOUND THAT THE INNER AIR HOSE IS CHIPPED OFF. THE SPRING (BEND PROTECTION) IS BROKEN. THE UNLOCKING SLEEVE IS DEFORMED AND DOES NOT SWITCH BACK TO ITS INTENDED POSITION BY ITSELF. IT IS MOST LIKELY THAT AN INAPPROPRIATE USAGE LED TO THE BREAKAGE OF THE SPRING. DUE TO THE RESULTING SHARP EDGES OF THE SPRING, THE COATING AT THE INNER HOSE WAS PROBABLY DAMAGED WHICH LED TO CHIPPING. DUE TO CHIPPING OF THE INNER HOSE AND THE RESULTING OVERPRESSURE, THE OUTER AIR HOSE LOST ITS FIXATION. THE DAMAGE OF THE UNLOCKING SLEEVE INDICATES A FALL OR IMPACT DAMAGE. ALSO, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), MAINTENANCE MUST TAKE PLACE AT LEAST ONCE PER YEAR. NO FAILURE COULD BE DETECTED AT THE PERFORATOR DRIVER. MAINTENANCE EXCEEDED "2017-09". FUNCTIONALLY, THE FOOT CONTROL IS IN ORDER. HOWEVER, WEAR AND TEAR CAN BE FOUND. A MAINTENANCE IS RECOMMENDED. THE HAND PIECE WAS DELIVERED IN 2008. A MAINTENANCE DID NOT TAKE PLACE SINCE THAT DATE ACCORDING TO OUR DATABASE. RUNNING NOISES CAN BE DETECTED AS WELL AS ROUGH TOOL LOCKING. THE INTERIOR AND BALL BEARINGS ARE STAINED WHICH ARE A CONSEQUENCE OF WEAR AND TEAR. A YEARLY MAINTENANCE IS RECOMMENDED FOR THAT PRODUCT. BATCH HISTORY REVIEW- THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS AND FOUND TO BE ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THERE IS NO INDICATION FOR A MATERIAL DEFECT OR MANUFACTURING ERROR. CONCLUSION AND ROOT CAUSE - THE FAILURE IS MOST LIKELY USAGE/WEAR AND TEAR (LACK OF MAINTENANCE) RELATED. RATIONALE - REFER TO INVESTIGATION ABOVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INTRAOPERATIVE ISSUE WITH THE DRILL HOSE AND COMPONENTS. DURING A SURGICAL PROCEDURE, THE TUBE SEEMED TO HAVE EXPLODED. THE DRILL WAS BEING USED MEDIAL TO THE LEFT CAROTID ARTERY. THE DEVICE WAS FUNCTIONALLY NORMALLY WHEN A LOUD HOUSE WAS HEARD COMING FROM THE HOSE; THERE WAS STRONG PRESSURE ON THE PEN, WHICH MOVED LATERALLY AND THEN INJURED THE LEFT CAROTID ARTERY. THERE WAS MASSIVE BLEEDING OF THE INTERNAL CAROTID ARTERY, LEFT, WHICH WAS ATTEMPTED TO BE CONTROLLED. THE PATIENT UNDERWENT ARTERIOGRAPHY WHICH SHOWED OCCLUSION OF THE LEFT INTERNAL CAROTID. PERFORMED DECOMPENSATED CRANIECTOMY, TO REDUCE RISK OF CEREBRAL HERNIATION. HOWEVER, THE PATIENT'S CONDITION DETERIORATED WITH SIGNIFICANT CEREBRAL SQUAMOSUM, WHICH ULTIMATELY LED TO BRAIN DEATH. ASSOCIATED MEDWATCHES: (CONCURRENT COMPONENTS REPORTED SEPARATELY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708582 FOOT CONTROL F/PNEUMATIC MOTORS HIGHSPEED POWER SYSTEMS HBB AESCULAP AG GA521 51513416

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L