BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO-SP-1/2X1/2"-STRL 20/CS

    MDR report key: 23290505 · Received October 15, 2025

    Report

    Report Number
    1060680-2025-00052
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    October 3, 2025
    Report Date
    January 27, 2026
    Manufacturer
    MEDSORB DOMINICANA, S.A.
    Product Code
    EFQ
    UDI-DI
    00749756037242
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "DURING PROCEDURE, CST REQUESTED ADDITIONAL 1/2"X1/2" COTTONOID PATTIES BE OPENED. OPENED AS REQUESTED. SHORTLY AFTER, CST NOTIFIED CIRCULATOR THAT A COTTONOID HAD THE GREEN STRIPE FALL OFF. CIRCULATOR CONFIRMED WITH CST THAT THE COTTONOID CAME FROM THE FRESHLY OPENED COTTONOIDS, AND NOT FROM THE PACK. CST CONFIRMED THE FAULTY COTTONOID WAS FROM THE SEPARATELY OPENED PACK. CST THEN CHECKED ALL THE 1/2" X 1/2" COTTONOIDS ON THE FIELD AND FOUND 1 ADDITIONAL COTTONOID WITH A LOOSE GREEN STRIPE. BOTH FAULTY COTTONOIDS REMOVED FROM THE FIELD, BOTH LOOSE GREEN STRIPES ALSO REMOVED FROM THE FIELD." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE BUT HAS NOT YET RECEIVED IT. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO THE SUPPLIER, (B)(4). 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, "DURING PROCEDURE, CST REQUESTED ADDITIONAL 1/2"X1/2" COTTONOID PATTIES BE OPENED. OPENED AS REQUESTED. SHORTLY AFTER, CST NOTIFIED CIRCULATOR THAT A COTTONOID HAD THE GREEN STRIPE FALL OFF. CIRCULATOR CONFIRMED WITH CST THAT THE COTTONOID CAME FROM THE FRESHLY OPENED COTTONOIDS, AND NOT FROM THE PACK. CST CONFIRMED THE FAULTY COTTONOID WAS FROM THE SEPARATELY OPENED PACK. CST THEN CHECKED ALL THE 1/2" X 1/2" COTTONOIDS ON THE FIELD AND FOUND 1 ADDITIONAL COTTONOID WITH A LOOSE GREEN STRIPE. BOTH FAULTY COTTONOIDS REMOVED FROM THE FIELD, BOTH LOOSE GREEN STRIPES ALSO REMOVED FROM THE FIELD.". DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, AND IT WAS RECEIVED ON 10/20/2025. UPON INSPECTION THE ISSUE WAS CONFIRMED AS THE GREEN X-RAY ELEMENT WAS OBSERVED TO BE COMING UNATTACHED. AN INVENTORY CHECK WAS PERFORMED ON ONE CASE OF THE RAW MATERIAL IN STOCK AND ALL WERE FOUND TO BE ACCEPTABLE. BECAUSE THIS IS A PURCHASED PART, DEROYAL DID NOT HAVE A RISK ANALYSIS TO REVIEW. A COMPLAINT TO SALES RATIO WAS CONDUCTED BETWEEN OCTOBER 2023 TO OCTOBER 2025 AND FOUND TO BE (B)(4). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE ISSUED TO THE SUPPLIER, (B)(4). 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 COULD 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. THIS PREVIOUS COMPLAINT NUMBER (B)(4) AND SUBMITTED WITH MDR # 1060680-2025-00004. 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, "DURING PROCEDURE, CST REQUESTED ADDITIONAL 1/2"X1/2" COTTONOID PATTIES BE OPENED. OPENED AS REQUESTED. SHORTLY AFTER, CST NOTIFIED CIRCULATOR THAT A COTTONOID HAD THE GREEN STRIPE FALL OFF. CIRCULATOR CONFIRMED WITH CST THAT THE COTTONOID CAME FROM THE FRESHLY OPENED COTTONOIDS, AND NOT FROM THE PACK. CST CONFIRMED THE FAULTY COTTONOID WAS FROM THE SEPARATELY OPENED PACK. CST THEN CHECKED ALL THE 1/2" X 1/2" COTTONOIDS ON THE FIELD AND FOUND 1 ADDITIONAL COTTONOID WITH A LOOSE GREEN STRIPE. BOTH FAULTY COTTONOIDS REMOVED FROM THE FIELD, BOTH LOOSE GREEN STRIPES ALSO REMOVED FROM THE FIELD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337748 NEURO-SP-1/2X1/2"-STRL 20/CS GAUZE/SPONGE, INTERNAL EFQ MEDSORB DOMINICANA, S.A. 30-054 24102694 00749756037242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown