BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO SPG-1X3"-STERILE- 20/CS

    MDR report key: 22749608 · Received August 8, 2025

    Report

    Report Number
    1060680-2025-00047
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    June 1, 2025
    Report Date
    November 14, 2025
    Manufacturer
    MEDSORB DOMINICANA, S.A.
    Product Code
    EFQ
    UDI-DI
    00749756037785
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "DURING THE PROCEDURE THE SURGEON WAS USING 1'X3" COTTONOIDS DURING A CRANIECTOMY AND THE RADIOPAQUE STRIP ON THE COTTONOID THAT WASN'T SEWN ONTO THE COTTONOID AND KEPT PEELING OFF OF THE COTTONOID AND INTO THE PATIENT. TWO OF THE COTTONOIDS HAD PEELED OFF AND THE SURGEON HANDED NURSE THE STRIPS BACK AND THE NURSE MADE SURE THEY WERE NOT MISSING ANY STRIPS FROM THE OTHER COTTONOIDS THAT WE HAD USED DURING THE CASE. THE NURSE THEN LAID ALL OF THE COTTONOIDS WITH THE STRIPS THAT HAD COME OFF TO VERIFY THAT ALL PIECES WERE RETRIEVED AND NOT LOST. " DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT IT HAS NOT YET BEEN RECEIVED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE ISSUED TO THE SUPPLIER, MEDSORB DOMINICANA, S.A. 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 THE PROCEDURE THE SURGEON WAS USING 1'X3" COTTONOIDS DURING A CRANIECTOMY AND THE RADIOPAQUE STRIP ON THE COTTONOID THAT WASN'T SEWN ONTO THE COTTONOID AND KEPT PEELING OFF OF THE COTTONOID AND INTO THE PATIENT. TWO OF THE COTTONOIDS HAD PEELED OFF AND THE SURGEON HANDED NURSE THE STRIPS BACK AND THE NURSE MADE SURE THEY WERE NOT MISSING ANY STRIPS FROM THE OTHER COTTONOIDS THAT WE HAD USED DURING THE CASE. THE NURSE THEN LAID ALL OF THE COTTONOIDS WITH THE STRIPS THAT HAD COME OFF TO VERIFY THAT ALL PIECES WERE RETRIEVED AND NOT LOST. " DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, AND A SAMPLE OF THE SAME PRODUCT WAS AVAILABLE FOR RETURN AND RECEIVED ON 8/14/2025. THE SAMPLE WAS INSPECTED AND IT WAS CLEAR THAT THE X-RAY STRIP WAS PEELING AWAY FROM THE SPONGE. DEROYAL REVIEWED THE WORK ORDER OF THE DEVICE AND NO ISSUES WERE FOUND. AN INVENTORY CHECK COULD NOT BE PERFORMED AS NO STOCK WAS AVAILABLE IN THE DISTRIBUTION FACILITY. BECAUSE THIS IS A PURCHASED PART, DEROYAL DID NOT HAVE A RISK ANALYSIS TO REVIEW. A COMPLAINT TO SALES RATIO WAS CONDUCTED BETWEEN AUGUST 2023 TO AUGUST 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 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.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 ON A MEDWATCH, "DURING THE PROCEDURE THE SURGEON WAS USING 1'X3" COTTONOIDS DURING A CRANIECTOMY AND THE RADIOPAQUE STRIP ON THE COTTONOID THAT WASN'T SEWN ONTO THE COTTONOID AND KEPT PEELING OFF OF THE COTTONOID AND INTO THE PATIENT. TWO OF THE COTTONOIDS HAD PEELED OFF AND THE SURGEON HANDED NURSE THE STRIPS BACK AND THE NURSE MADE SURE THEY WERE NOT MISSING ANY STRIPS FROM THE OTHER COTTONOIDS THAT WE HAD USED DURING THE CASE. THE NURSE THEN LAID ALL OF THE COTTONOIDS WITH THE STRIPS THAT HAD COME OFF TO VERIFY THAT ALL PIECES WERE RETRIEVED AND NOT LOST. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490469 NEURO SPG-1X3"-STERILE- 20/CS GAUZE/SPONGE, INTERNAL EFQ MEDSORB DOMINICANA, S.A. 30-060 2410700 00749756037785

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown