BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY SCALPEL

    MDR report key: 4910099 · Received July 8, 2015

    Report

    Report Number
    3004605321-2015-00013
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    June 5, 2015
    Report Date
    July 7, 2015
    Manufacturer
    DEROYAL INTERCONTINENTAL, S.A.L
    Product Code
    GES
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE QFI REPORT WAS REVIEWED FOR THE SALES AND SIMILAR COMPLAINT INFO. DEROYAL HAS SOLD (B)(4) CASES OF THE FINISHED GOOD FROM 2013 TO PRESENT. THERE HAVE BEEN NO PREVIOUS REPORTS IN WHICH AN ISSUE HAS BEEN PRESENT DUE TO NOT HAVING LABELING DETAILING THE MANNER IN WHICH THE BLADE EXTENDS. CORRECTION: A CORRECTION HAS NOT BEEN TAKEN. ROOT CAUSE ANALYSIS: THE END USER PERFORMED A KNOWLEDGE-BASED ERROR AND DID NOT FOLLOW THE INSTRUCTIONS FOR USE. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: DUE TO THE INVESTIGATION AND ROOT CAUSE DETERMINATION, A CORRECTIVE ACTION HAS NOT BEEN TAKEN. PREVENTIVE ACTION: DUE TO THE INVESTIGATION AND ROOT CAUSE DETERMINATION, A PREVENTIVE ACTION HAS NOT BEEN TAKEN. THE INVESTIGATION IS COMPLETE AT THIS TIME. THIS REPORT WILL BE UPDATED IF MORE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT RECEIVED FROM VNUS MEDICAL TECHNOLOGIES REGARDING THE SAFETY SCALPEL, 11 SS NS, PART #D4511A, SUPPLIER LOT # 38440124. A DOCTOR REPORTED CONCERNS WITH THE DESIGN OF THE SCALPEL. THIS ISSUE IS WHEN YOU SLIDE OPEN (IF YOU ARE NOT PAYING CLOSE ATTENTION), THERE IS NO LABEL STATING WHICH WAY TO OPEN THE SHARP END; AND IF IT'S TURNED OVER, YOU CANNOT TELL AS WELL. THIS IS NOT A LOT SPECIFIC COMPLAINT. THE DOCTOR CUT HIMSELF USING IT; HOWEVER, HE WAS ABLE TO CONTINUE DOING THE CASE BUT WAS CONCERNED FOR FUTURE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441599 SAFETY SCALPEL HANDLE, SCALPEL GES DEROYAL INTERCONTINENTAL, S.A.L 38440124

    Patients

    Seq Age Sex Outcome Treatment
    1