MAUDE Adverse Event Report: MEDSORB DOMINICANA, S.A. NEURO SPNG-1/2X3"-STRL- 20/CS; GAUZE/SPONGE, INTERNAL

Model Number	30-057
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported, "product used in endoscopic sinus surgery with epinephrine.Small fibers were left behind in nasal cavity when sponges were removed.".
Additional Manufacturer Narrative
A user facility reported, "product used in endoscopic sinus surgery with epinephrine.Small fibers were left behind in nasal cavity when sponges were removed." deroyal industries, inc.Requested return of the device, but it has yet to be received.A supplier corrective action request (scar) has been 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
A user facility reported, "product used in endoscopic sinus surgery with epinephrine.Small fibers were left behind in nasal cavity when sponges were removed." deroyal industries, inc.Requested return of the device, but it was not received.The device history record was reviewed and no issues were found.Deroyal reviewed inventory on hand and did not find any issues with the fibers.A complaint to sales ratio was conducted over the past two years and found to be (b)(4).A supplier corrective action request (scar) has been issued to the supplier, (b)(4).The supplier reviewed their device history record, complaint records, and intended use verification.The device history record reviewed did not identify any issues within manufacturing.It was reviewed that the complaint stated that the product was used in a sinus surgery which is not within the scope of the intended use which should only be used for neurological procedures.Root cause: the product was used in an endoscopic sinus surgery, which is outside the intended use.The product is intended for neurological procedures only.Use in a different anatomical site, like nasal cavity, may result in unintended interaction with tissue, including the perception of fiber residue.Corrective or preventive actions: because the cause was traced to user error, 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.

• Brand Name: NEURO SPNG-1/2X3"-STRL- 20/CS
• Common Device Name: GAUZE/SPONGE, INTERNAL
• Manufacturer (Section D): MEDSORB DOMINICANA, S.A.; zona franca industrial park; san pedro de marcoris, ; DO
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 24222137
• Report Number: 1060680-2026-00002
• Device Sequence Number: 8085503
• Product Code: EFQ
• UDI-Device Identifier: 00749756035910
• UDI-Public: 00749756035910
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K791871
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 30-057
• Device Lot Number: 25061938
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown