BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY SCALPEL, #11 500/CASE, 500/DOUBLE POLYBAG

    MDR report key: 19951461 · Received August 9, 2024

    Report

    Report Number
    2320762-2023-00018
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    November 20, 2023
    Report Date
    December 18, 2023
    Manufacturer
    S&S SURGICAL PRODUCTS INC
    Product Code
    GDX
    UDI-DI
    00749756350884
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DISTRIBUTING FACILITY REPORTED, "BLADE FROM SAFETY SCALPEL WAS NOT SECURED WITHIN THE CASE. ON MANUFACTURING AREA 2 PERSONS HAVE ACCIDENTALLY CUT THEIR HAND DUE THE BLADE OF K-15703-013A WAS NOT SECURED IN PLACE. " DEROYAL INDUSTRIES REQUESTED THE RETURN OF THE DEVICE, HOWEVER THE FACILITY STATED IT WAS NOT AVAILABLE FOR RETURN. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE SENT TO THE SCALPEL MANUFACTURER, S&S SURGICAL PRODUCTS. THE INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    DEROYAL INDUSTRIES REQUESTED THE RETURN OF THE DEVICE, HOWEVER THE FACILITY STATED IT WAS NOT AVAILABLE FOR RETURN. DEROYAL PERFORMED AN INVENTORY CHECK ON 500 SCALPELS AND REVIEWED 120 WORK ORDERS AND NO ISSUES WERE DISCOVERED. A COMPLAINT TO SALES RATIO WAS COMPLETED BETWEEN OCTOBER 2021 THROUGH OCTOBER 2023 AND WAS CALCULATED TO BE 0.0000017 OR 0.00017%. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SENT TO THE SCALPEL MANUFACTURER, S&S SURGICAL PRODUCTS. S&S SURGICAL INSPECTED IN PROCESS ASSEMBLY AND PACKAGING AND NO ISSUES WERE FOUND. THEY ALSO INSPECTED INVENTORY ON HAND AS WELL AS ASSEMBLYING A SAMPLE LOT OF 20 TO INSPECT FUNCTION. NO ISSUES WERE FOUND WITHIN INVENTORY AND ALL SAMPLES PASSED FUNCTION TESTING AS DESIGNED. ROOT CAUSE: BECAUSE THE SAMPLE WAS NOT RETURNED AND NO ISSUES WERE IDENTIFIED IN PROCESS INSPECTIONS, NO ROOT CAUSE COULD BE IDENTIFIED. POTENTIAL ROOT CAUSE: IT WAS SPECIFICALLY NOTED BY S&S SURGICAL THAT THIS ISSUE COULD HAVE OCCURED IN TRANSIT. IT WAS ALSO NOTED THAT WARNING LABELS ARE INSTALLED ON ALL BOXES DUE TO POTENTIAL ISSUES OCCURING IN TRANSIT. CORRECTIVE AND PREVENTIVE ACTION: BECAUSE NO ROOT CAUSE COULD BE DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THE INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A DISTRIBUTING FACILITY REPORTED, "BLADE FROM SAFETY SCALPEL WAS NOT SECURED WITHIN THE CASE. ON MANUFACTURING AREA 2 PERSONS HAVE ACCIDENTALLY CUT THEIR HAND DUE THE BLADE OF K-15703-013A WAS NOT SECURED IN PLACE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2246836 SAFETY SCALPEL, #11 500/CASE, 500/DOUBLE POLYBAG SCALPEL, ONE-PIECE GDX S&S SURGICAL PRODUCTS INC D4511NS-500 58616211 00749756350884

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability| O