BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY SCALPEL

    MDR report key: 8691144 · Received June 12, 2019

    Report

    Report Number
    1060680-2019-00008
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    May 10, 2019
    Report Date
    June 12, 2019
    Manufacturer
    S & S SURGICAL
    Product Code
    GDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE SCALPEL IS SUPPLIED TO DEROYAL BY S & S SURGICAL. A SUPPLIER CORRECTIVE ACTION REPORT WAS ISSUED TO S & S SURGICAL. IN ITS RESPONSE, THE SUPPLIER STATED THAT A ROOT CAUSE COULD NOT BE DETERMINED. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE MACHINE AND INSPECTION SYSTEM WERE FOUND TO BE FUNCTIONING PROPERLY. TO INVESTIGATE FURTHER, THE PHYSICAL SAMPLE IS NEEDED. THE BOX IS LABELED THAT THE BLADES MAY BECOME EXPOSED DURING SHIPPING. CORRECTIVE ACTION: NO CORRECTIVE ACTION WAS TAKEN BASED ON THE ROOT CAUSE DETERMINATION. INVESTIGATION SUMMARY AN INTERNAL COMPLAINT (CALL 47190) WAS RECEIVED FOR A SCALPEL (PART SM4511NS) WITH AN EXPOSED BLADE, RESULTING IN AN INJURY WHEN UNPACKING A BAG. A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR RETURN. PHOTOS WERE PROVIDED OF THE REPORTED ISSUE. THE WORK ORDER WAS CHECKED AND SHOWED NO DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE WAS NO STOCK ON HAND TO CHECK. THE SCALPEL IS SUPPLIED TO DEROYAL BY S & S SURGICAL. A SUPPLIER CORRECTIVE ACTION REPORT (SCAR) WAS ISSUED TO S & S SURGICAL. THE RESPONSE WAS RECEIVED AND ACCEPTED MAY 21, 2019 BY DEROYAL PERSONNEL. THE SUPPLIER ADDS A WARNING LABEL TO THE BOX WHICH STAYS ON THE PRODUCT WHEN SHIPPED FOR COMMERCIAL DISTRIBUTION. THIS LABEL STATES THE FOLLOWING: "WARNING - DO NOT REACH HAND INTO BOX. BLADES MAY BECOME EXPOSED DURING SHIPMENT." SINCE APRIL 2017, A TOTAL OF (B)(4) UNITS HAVE BEEN SOLD WITH A SALES-TO-COMPLAINT RATIO OF (B)(4). THERE HAVE BEEN FIVE COMPLAINTS DURING THIS TIME FRAME. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    EMPLOYEE WAS REMOVING SCALPEL FROM INNER BAG AND WAS STABBED BY THE SCALPEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484919 SAFETY SCALPEL HANDLE, SCALPEL GDZ S & S SURGICAL SM4511NS 013513

    Patients

    Seq Age Sex Outcome Treatment
    1