BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETYSCALPEL ASMBD #3 FITMENT, #11 BLADE, BLUE NS

    MDR report key: 21987317 · Received May 8, 2025

    Report

    Report Number
    1060680-2025-00024
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    May 6, 2025
    Report Date
    July 1, 2025
    Manufacturer
    S&S SURGICAL PRODUCTS INC
    Product Code
    GDZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DISTRIBUTING FACILITY REPORTED, "PROTRUDING BLADE STABBED OPERATIVE DURING UNPACKING." DEROYAL INDUSTRIES INC. REQUESTED RETURN OF THE DEVICE BUT IT WAS NOT AVAILABLE. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE SENT TO THE SUPPLIER. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A DISTRIBUTING FACILITY REPORTED, "PROTRUDING BLADE STABBED OPERATIVE DURING UNPACKING." DEROYAL INDUSTRIES INC. REQUESTED RETURN OF THE DEVICE BUT IT WAS NOT AVAILABLE. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SENT TO THE SUPPLIER S&S SURGICAL. THE SUPPLIER REVIEWED ASSEMBLY PROCESS AND INVENTORY ON HAND AND NO ISSUES WERE FOUND. ALL PRODUCTS PASS THROUGH A DETECTION SYSTEM THAT WILL NOT ALLOW FOR SCALPELS TO PASS THROUGH IF THE BLADE IS EXPOSED. OPERATORS ALSO INSPECT PARTS IN PROCESS. NO ISSUES HAVE BEEN FOUND INTERNALLY. INVENTORY WAS ALSO REVIEWED WITH NO ISSUES FOUND. WARNING LABELS ARE ALSO PLACED ON ALL BOXES WARNING THAT BLADES COULD POTENTIALLY PROTRUDE WHILE IN TRANSIT. DEROYAL INDUSTRIES REVIEWED WORK ORDERS FOR THE LOT AND NO ISSUES WERE FOUND. DEROYAL WAS UNABLE TO REVIEW INVENTORY AS NO SAFETY SCALPELS WERE FOUND ON HAND. A COMPLAINT TO SALES RATIO WAS CONDUCTED FROM MAY 2023 TO MAY 2025 AND FOUND TO BE (B)(4) ROOT CAUSE: BECAUSE THE SAMPLE WAS UNABLE TO BE RETURNED AND NO SPECIFIC ISSUES COULD BE IDENTIFIED IN PRODUCTION RECORDS, NO ROOT CAUSE WAS ABLE TO BE DETERMINED. HOWEVER, BECAUSE THESE PRODUCTS ARE SHIPPED IN BULK BOXES FOR FURTHER PACKAGING, THESE PRODUCTS ARE SHIPPED WITH WARNING LABELS STATING THAT BLADES COULD PROTRUDE IN SHIPPING AS IT IS A COMMON ISSUE THAT CAN HAPPEN WITHIN THE BOXES IN TRANSIT. CORRECTIVE OR PREVENTIVE ACTIONS: BECAUSE NO SPECIFIC ROOT CAUSE WAS ABLE TO BE DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. 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

    A DISTRIBUTING FACILITY REPORTED, "PROTRUDING BLADE STABBED OPERATIVE DURING UNPACKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761066 SAFETYSCALPEL ASMBD #3 FITMENT, #11 BLADE, BLUE NS HANDLE, SCALPEL GDZ S&S SURGICAL PRODUCTS INC SM4511NS 025289

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other