BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO QR3 SKULL CLAMP

    MDR report key: 10710361 · Received October 21, 2020

    Report

    Report Number
    3003923584-2020-00026
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    September 22, 2020
    Report Date
    September 23, 2020
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    UDI-DI
    04250435506196
    PMA / PMN Number
    K001808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS INJURED IN THIS CASE, BUT DUE TO THE POTENTIAL RISK WE DECIDED TO REPORT THIS CASE. THE DEVICE WAS INSPECTED AND TESTED ON 14TH OF OCTOBER 2020. WITHIN THIS INSPECTION, FUNCTIONAL TESTING AND VISUAL INSPECTION WAS MADE. THE RESULT WAS: NO FAILURE FOUND THAT COLD CONTRIBUTE TO THE REPORTED EVENT. THEREFORE, WE SUSPECT, THAT MAYBE THE PINNING TECHNIQUE HAS BEEN NOT OPTIMAL AS DESCRIBED IN THE INSTRUCTION MANUAL: "ADJUST THE SKULL CLAMP TO THE WIDTH OF THE PATIENT'S HEAD IN THE MANNER THAT THE TWO SKULL PINS IN THE ROCKER ARM ARE EQUIDISTANT FROM THE CENTERLINE OF THE HEAD AND THE SINGLE SKULL PIN AT THE EXTENSION ASSEMBLY IS IN LINE WITH THIS CENTERLINE."

    Description of Event or Problem · 1

    CUSTOMER SERVICE HAS BEEN CONTACTED ON 23RD SEPTEMBER 2020 BY DISTRIBUTOR. DISTRIBUTOR STATED THAT THEIR CUSTOMER REPORTED AN INCIDENT ON (B)(6) 2020 WITH THE FOLLOWING DESCRIPTION: LATERAL POSITIONING OF THE PATIENT. FIXATION OF THE SKULL CLAMP WITH 2-PIN SIDE AT FOREHEAD AND 1-PIN SIDE OCCIPITAL. CHECK OF ALL CRITICAL CONNECTIONS AT THE SKULL CLAMP AND THE BASE UNIT. PREPARATION OF THE PATIENT AND CHECK OF NAVIGATION. VERY GOOD ACCURACY. AFTER SKIN INCISION A HEAD MOVEMENT HAS BEEN DETECTED AND NAVIGATION INDICATES A SHIFT. SKULL CLAMP SEEMED TO BE FIXED. WE ARE SUSPECTING THAT THE PRESSURE MECHANISM HAS BEEN YIELDING. THE FIXATION OF THE SKULL CLAMP ON THE HEAD IS NO LONGER SUFFICIENT. A SLIGHTLY ROTATION OF THE HEAD HAS BEEN DETECTED. THIS MOVEMENT CAUSED THE SHIFT OF THE NAVIGATION. SKULL CLAMPS HAS BEEN REPLACED (APPROXIMATELY 30 MIN DELAY OF SURGERY). NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176526 DORO QR3 SKULL CLAMP DORO® QR3 SKULL CLAMP HBL PRO MED INSTRUMENTS GMBH 1001.001 04250435506196

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR