BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO® SKULL CLAMP

    MDR report key: 7057672 · Received November 24, 2017

    Report

    Report Number
    3003923584-2017-00047
    Event Type
    Malfunction
    Date Received
    November 24, 2017
    Date of Event
    October 25, 2017
    Report Date
    October 26, 2017
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    UDI-DI
    04250435501689
    PMA / PMN Number
    K001808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY WAS REPORTED, BUT AS THERE WAS A POTENTIAL RISK REPORTED ("SKULL CLAMP OPENED") WE DECIDED TO REPORT THIS CASE. THE DEVICE WAS INSPECTED AND TESTED. WITHIN THIS INSPECTION FUNCTIONAL TESTING AND VISUAL INSPECTION WAS MADE. IT IS VERY UNLIKELY THAT THE DETECTED DEVIATIONS HAVE CONTRIBUTED TO THE REPORTED EVENT - "MUTLI PURPOSE CLAMP HAD OPENED"- 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."

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON DECEMBER 12TH 2017. THIS INFORMATION GAVE US A CLEARER PICTURE OF THE SITUATION. THE REPORTER INFORMED US, THAT THE RELEASE KNOP WAS INCIDENTLY OPENED.

    Description of Event or Problem · 1

    DURING OPERATION PROCEDURE WITH NEURONAVIGATION MULTI PURPOSE CLAMP HAD OPENED. CONTINUATION OF THE OPERATION WITH NEURONAVIGATION NOT POSSIBLE. OPERATION WAS COMPLETED BY NEUROSURGEON ASSISTANT HOLDING CHILDREN HEAD IN HAND. MEDICAL INCIDENT WAS DECLARED.

    Description of Event or Problem · 1

    ADDITIONALLY INFORMATION RECEIVED ON DECEMBER 12TH 2017: THE CLAMP WAS INCIDENTLY OPENED, DURING THE SURGERY SOMEONE REACHED THE KNOB OF THE RELEASE KNOB OF THE SKULL CLAMP, WHICH OPENED THE SKULL CLAMP. THE RISK WAS BEING SEEN IN THE HEAD BEING ABLE TO FALL DOWN TO THE METAL PARTS OF THE SKULL CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837114 DORO® SKULL CLAMP DORO® MULTI-PURPOSE SKULL CLAMP HBL PRO MED INSTRUMENTS GMBH 3020-50 04250435501689

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention