BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO® QR3 SKULL CLAMP

    MDR report key: 7002755 · Received November 6, 2017

    Report

    Report Number
    3003923584-2017-00046
    Event Type
    Injury
    Date Received
    November 6, 2017
    Date of Event
    October 9, 2017
    Report Date
    October 9, 2017
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    PMA / PMN Number
    K001808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS INSPECTED AND TESTED ON 16TH OCTOBER 2017. WITHIN THIS INSPECTION FUNCTIONAL TESTING AND VISUAL INSPECTION WAS MADE. THE RESULT WAS: => THE DEVICE WAS SLIGHTLY OUT OF SPECIFICATION. => INTERVAL OF THE SUPPLIER MAINTENANCE WAS EXCEEDED BY THE CUSTOMER. AS THE DEVICE DID NOT SHOW ANY DEVIATION THAT COULD CAUSE THE REPORTED INCIDENT 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 WAS CONTACTED ON OCT 09TH 2017 BY DISTRIBUTOR: DISTRIBUTOR STATED THAT AN INCIDENT HAS HAPPENED AND PROVIDED DETAILS VIA RETURNED GOOD FORM ON OCT 11TH 2017: DESCRIPTION: PATIENT HEAD FELL OUT OF CLAMP. INJURIES: CUT SIDE HEAD. PATIENT POSITIONING: FACE DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783850 DORO® QR3 SKULL CLAMP DORO® QR3 SKULL CLAMP HBL PRO MED INSTRUMENTS GMBH 1001.001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention