MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. THORACOSCOPY / THORACOTOMY; GENERAL SURGERY TRAY (KIT)

Model Number	89-10576
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Hair found in lap sponges.
Additional Manufacturer Narrative
A complaint was received on 1/12/2023 reporting hair found in lap sponges.A supplier corrective action request (scar) was issued to the lap sponge supplier gd medical.The sample has not been returned to deroyal for evaluation at this time.This investigation is ongoing at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Additional Manufacturer Narrative
The sample was not provided to deroyal for evaluation.A supplier corrective action request (scar) was issued to the lap sponge supplier gd medical.Root cause: was determined by the supplier gd medical as certain workers in the folding workshop were not properly following the gowning procedure.The following corrective and preventive actions have been taken by gd medical: workers in the folding workshop were re-trained on the gowning procedure to avoid any hair left on the products.Workshop supervisors have been notified of this incident.They will monitor and provide guidance on proper gowning of each worker during production.Supervisors of the other manufacturing process and quality assurance have been notified of this incident.Quality assurance will monitor for any reoccurrence of the same issue during in-process and finished product inspections.Production records were reviewed, and no issues were found.An inventory check of the lab sponges was made by deroyal, a total of 12 of the 5-1918 was inspected, and no discrepancies were identified during the inspection.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: THORACOSCOPY / THORACOTOMY
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 16203192
• Report Number: 3005011024-2023-00003
• Device Sequence Number: 5454506
• Product Code: LRO
• UDI-Device Identifier: 00749756364126
• UDI-Public: 00749756364126
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K842648
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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
• Device Model Number: 89-10576
• Device Catalogue Number: 89-10576
• Device Lot Number: 58009075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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