BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO SPONGE 1/2 X 2 20/CS

    MDR report key: 22188516 · Received June 11, 2025

    Report

    Report Number
    1060680-2025-00039
    Event Type
    Malfunction
    Date Received
    June 11, 2025
    Date of Event
    June 10, 2025
    Report Date
    August 28, 2025
    Manufacturer
    MEDSORB DOMINICANA, S.A.
    Product Code
    EFQ
    UDI-DI
    00749756037877
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "THE STRING PULLED OFF WHILE ITEM WAS BEING USED ON A PATIENT, USERS VOCALIZED THERE WAS NO ACCIDENTAL CUTTING OR CAUTERY USE AT THE TIME OF FAILURE." DEROYAL INDUSTRIES REQUESTED RETURN OF THE DEVICE BUT IT WAS NOT AVAILABLE. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE ISSUED 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 USER FACILITY REPORTED, "THE STRING PULLED OFF WHILE ITEM WAS BEING USED ON A PATIENT, USERS VOCALIZED THERE WAS NO ACCIDENTAL CUTTING OR CAUTERY USE AT THE TIME OF FAILURE." DEROYAL INDUSTRIES REQUESTED RETURN OF THE DEVICE BUT IT WAS NOT AVAILABLE. DEROYAL REVIEWED THE WORK ORDER OF THE DEVICE AND NO ISSUES WERE FOUND. AN INVENTORY CHECK WAS ALSO PERFORMED ON ONE CASE OF THE NEUROSPONGES. ALL STRINGS WERE ATTACHED AND NO ISSUES WERE FOUND. BECAUSE THIS IS A PURCHASED PART, DEROYAL DID NOT HAVE A RISK ANALYSIS TO REVIEW. A COMPLAINT TO SALES RATIO WAS CONDUCTED BETWEEN JUNE 2023 TO JUNE 2025 AND FOUND TO BE 0.007%. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE ISSUED TO THE SUPPLIER, MEDSORB DOMINICANA, S.A. THE SUPPLIER REVIEWED THE DEVICE HISTORY RECORD (DHR) AND REVIEWED A PREVIOUS SIMILAR COMPLAINT. DUE TO THE PREVIOUS COMPLAINT, IT WAS NOTICED THAT WHEN MATERIAL THICKNESS VARIATIONS WOULD OCCUR, THE PRODUCTION ASSOCIATES WOULD ADJUST THE HORN CLEARANCE BUT FAIL TO VERIFY IF THE ADJUSTMENT WAS WITHIN THE SPECIFIED PARAMETERS. WITHIN THE PREVIOUS COMPLAINT, CORRECTIVE ACTIONS WERE TAKEN, BUT THIS LOT WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THOSE ACTIONS. ROOT CAUSE: BECAUSE THE SAMPLE WAS NOT ABLE TO BE DETERMINED, THE SPECIFIC ROOT CAUSE WAS NOT ABLE TO BE DETERMINED, HOWEVER, WITH THE PREVIOUS COMPLAINT, A POTENTIAL ROOT CAUSE WOULD BE THAT WHEN MATERIAL THICKNESS VARIATIONS WOULD OCCUR, THE PRODUCTION ASSOCIATES WOULD ADJUST THE HORN CLEARANCE BUT FAIL TO VERIFY IF THE ADJUSTMENT WAS WITHIN THE SPECIFIED PARAMETERS. CORRECTIVE AND PREVENTIVE ACTIONS: CORRECTIVE AND PREVENTIVE ACTIONS WERE TAKEN ON THE PREVIOUS COMPLAINT AND WOULD ALSO APPLY TO THIS POTENTIAL ROOT CAUSE. THESE ACTIONS INCLUDED: NEW HORNS WITH WELDER TIPS THAT PROVIDE MORE STABILITY TO THE MATERIAL. ADDITIONALLY, WORK INSTRUCTIONS WERE UPDATED TO MANDATE THE VERIFICATION OF THE DISTANCE BETWEEN THE HORN AND THE ANVIL. WITH COMPLAINT SPECIFICALLY, A RETRAINING WAS CONDUCTED FOR ALL THE OPERATORS AND SUPERVISORS ON CORRECT WELD SETUP. 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 USER FACILITY REPORTED, "THE STRING PULLED OFF WHILE ITEM WAS BEING USED ON A PATIENT, USERS VOCALIZED THERE WAS NO ACCIDENTAL CUTTING OR CAUTERY USE AT THE TIME OF FAILURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70030 NEURO SPONGE 1/2 X 2 20/CS GAUZE/SPONGE, INTERNAL EFQ MEDSORB DOMINICANA, S.A. 30-068 24112881 00749756037877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown