BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFETY SCALPEL, 22 BLADE LIGHT/SKY BLUE NS

    MDR report key: 19928475 · Received August 7, 2024

    Report

    Report Number
    1060680-2022-00004
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    November 25, 2022
    Report Date
    January 13, 2023
    Manufacturer
    S & S SURGICAL PRODUCTS INC.
    Product Code
    GDZ
    UDI-DI
    00749756811552
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY COMPLAINT WAS RECEIVED ON 11/25/2022, REPORTING, "WE HAVE RECEIVED A RATHER SERIOUS CUSTOMER COMPLAINT WHERE AN END-USER HAS CUT THEMSELVES ON A CONTAMINATED NO22 RETRACTABLE SCALPEL. THE SCALPEL HAS BEEN USED AND THEN THE BLADE HAS BEEN RETRACTED INTO THE PASSING POSITION. DUE TO THE TIGHTNESS OF THE TRIGGER, THE TIP OF THE BLADE HAS NOT BEEN FULLY RETRACTED IN THE SCALPEL AND THEY HAVE CUT THEMSELVES." NO ADDITIONAL INFORMATION REPORTED. PATIENT STATUS IS UNKNOWN. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SAFETY SCALPEL SUPPLIER (B)(4). THE SAMPLE IS NOT AVAILABLE FOR RETURN TO DEROYAL FOR EVALUATION. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT ONCE MORE INFORMATION IS CONCLUDED FROM THE INVESTIGATION AND CORRECTIVE ACTIONS ARE DETERMINED.

    Additional Manufacturer Narrative · 0

    A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SAFETY SCALPEL SUPPLIER (B)(4). THE SAMPLE IS NOT AVAILABLE FOR RETURN TO DEROYAL FOR EVALUATION. ROOT CAUSE: WAS DETERMINED TO BE UNKNOWN. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND WAS OVER 5 YEARS OLD. IT WAS NOTED THAT THIS WAS ONLY COMPLAINT OF THE (B)(4) PIECES PRODUCED IN THIS LOT. A (B)(4) PIECE SAMPLE SIZE WAS MADE FOR TESTING AND NO DEFECTS WERE FOUND. NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN BY (B)(6), BUT THEY WILL CONTINUE TO MONITOR FOR TRENDS. DEROYAL CONDUCTED A REVIEW OF THE WORK ORDERS AND FAILURE MODES AND EFFECT ANALYSIS (FMEA) WAS IT FOUND TO HAVE NO DISCREPANCIES. AN INVENTORY CHECK WAS PERFORMED BY DEROYAL WITH (B)(4) SAFETY SCALPELS WERE INSPECTED WITH NO DISCREPANCIES FOUND. DEROYAL HAS SOLD (B)(4) CASES OF FINISHED GOOD ITEM (B)(6) FROM (B)(6) 2020 TO PRESENT AND DURING THIS REVIEW PERIOD A TOTAL OF (B)(4) COMPLAINT HAS BEEN RECEIVED FOR THIS ITEM. THIS EQUATES TO A SALES RATIO OF (B)(4). DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS RELATED TO THIS COMPLAINT. ADDITIONAL INFORMATION WAS RECEIVED DECEMBER 5 AND INTERNALLY APPROVED ON DEC 12. THIS FOLLOW UP MDR IS BEING SUBMITTED AFTER THE 30 DAY MARK DUE TO AN INTERNAL ADMINISTRATIVE ERROR. THIS 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

    WE HAVE RECEIVED A RATHER SERIOUS CUSTOMER COMPLAINT WHERE AN END-USER HAS CUT THEMSELVES ON A CONTAMINATED NO22 RETRACTABLE SCALPEL. THE SCALPEL HAS BEEN USED AND THEN THE BLADE HAS BEEN RETRACTED INTO THE PASSING POSITION. DUE TO THE TIGHTNESS OF THE TRIGGER, THE TIP OF THE BLADE HAS NOT BEEN FULLY RETRACTED IN THE SCALPEL AND THEY HAVE CUT THEMSELVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580846 SAFETY SCALPEL, 22 BLADE LIGHT/SKY BLUE NS HANDLE, SCALPEL GDZ S & S SURGICAL PRODUCTS INC. D4522NS 49415223 00749756811552

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other