BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO® SKULL CLAMP

    MDR report key: 8127976 · Received December 4, 2018

    Report

    Report Number
    3003923584-2018-00062
    Event Type
    Malfunction
    Date Received
    December 4, 2018
    Report Date
    November 5, 2018
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    PMA / PMN Number
    K001808
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IN THIS FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    AS OF TODAY 3 OF 7 RECEIVED SKULL CLAMPS WERE INSPECTED. WITHIN THIS INSPECTION FUNCTIONAL TESTING AND VISUAL INSPECTION WAS MADE. NO DEVIATION WAS FOUND. 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." 4 OF 7 SKULL CLAMPS WERE NOT YET RECEIVED AND THEREFORE NO EVALUATION WAS POSSIBLE AS THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    CUSTOMER SERVICE WAS CONTACTED ON 5TH NOVEMBER 2018 BY DISTRIBUTOR STATING THAT THEY HAD 2 INCIDENCES WHERE A PATIENT SLIPPED AFTER THE PRESSURE SCREW WAS TIGHTENED. CUSTOMER STATED THAT THERE WAS NO PATIENT INJURY. FURTHERMORE THE CUSTOMER STATED THAT THEY WILL SEND IN 7 SKULL CLAMPS FOR INSPECTION, BUT THEY CAN'T TELL WHICH CLAMPS WERE USED WHEN THE SLIPPAGE HAPPEND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967166 DORO® SKULL CLAMP DORO® SKULL CLAMP HBL PRO MED INSTRUMENTS GMBH 3003-009

    Patients

    Seq Age Sex Outcome Treatment
    1