BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO® SKULL CLAMP

    MDR report key: 8045681 · Received November 7, 2018

    Report

    Report Number
    3003923584-2018-00054
    Event Type
    Malfunction
    Date Received
    November 7, 2018
    Date of Event
    October 8, 2018
    Report Date
    October 10, 2018
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    PMA / PMN Number
    K001808
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS FOLLOW-UP 1: THE DEVICE WAS RECEIVED ON 22TH OCTOBER 2018. CONDUCTED VISUAL AND FUNCTIONAL TESTING/INSPECTION. RESULT: INDEX KNOB NEEDE MINOR REPAIR: CLEANING, ADJUSTING AND REPLACING SEALING RINGS AND WASHERS. WE SUPPOSE NORMAL WEAR AND TEAR AND MINOR DEBRIS FROM REPROCESSING PROCESS AS ROOT CAUSE FOR THE REPORTED DEVIATION. CONCERNING THE REPORTED EVENT: FROM OUR EXPERIENCE IT IS UNLIKELY THAT THE LOOSENESS IN THE INDEX KNOB HAS CONTRIBUTED TO THE REPORTED EVENT. OUR EXPERIENCE IS, THAT 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 10TH OCTOBER 2018 BY CUSTOMER. CUSTOMER STATED: "SWIVEL ARM SLIPPED WHILE POSITIONING PATIENT". PATIENT WAS INJURED, 1 CM LACERATION RIGHT SCALP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886579 DORO® SKULL CLAMP DORO® SKULL CLAMP HBL PRO MED INSTRUMENTS GMBH 3003-009

    Patients

    Seq Age Sex Outcome Treatment
    1