BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO® SKULL CLAMP

    MDR report key: 7994915 · Received October 23, 2018

    Report

    Report Number
    3003923584-2018-00048
    Event Type
    Malfunction
    Date Received
    October 23, 2018
    Date of Event
    September 19, 2019
    Report Date
    September 24, 2018
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    PMA / PMN Number
    K001808
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS FOLLOW-UP 1: THE DEVICE WAS RECEIVED ON (B)(6) 2018. CONDUCTED VISUAL AND FUNCTIONAL TESTING/INSPECTION ON (B)(6). RESULT: DEFECT OPEN/LOCK MECHANISM: CLEANING AND STERILIZATION RESIDUES BLOCK THE CATCH CLAMPING MECHANISM. INCIDENT: WE COULD NOT FIND A CONNECTION OF THE FAILURE AND THE INCIDENT. IT COULD BE, THAT THE USER HAS NOT REALIZED, THAT THE SKULL CLAMP IS NOT PROPERLY CLOSING. BY THIS, A MOVEMENT MAY HAVE OCCURED. ALSO, OUR EXPERIENCE IS, THAT INCORRECT PINNING TECHNIQUE CAN CONTRIBUTE TO SLIPPAGES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IN THIS FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    NO EVALUATION POSSIBLE AS THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    CUSTOMER SERVICE WAS CONTACTED ON (B)(6) 2018. CUSTOMER STATED: "PATIENT SLIPPED IN SKULL CLAMP ON WEDNESDAY (B)(6) 2018 DURING A CASE. THE COLLEAGUE HAS APPLIED IT HIMSELF AND IT GAVE WAY A FEW HOURS INTO THE CASE. WE HAD TO SEMI-CLOSE THE WOUND, UNDRAPE, REPIN, REDO NAVIGATION AND RESTART AGAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834402 DORO® SKULL CLAMP DORO® SKULL CLAMP HBL PRO MED INSTRUMENTS GMBH 1001.001

    Patients

    Seq Age Sex Outcome Treatment
    1