MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. ROBOTIC PACK; GENERAL SURGERY TRAY (KIT)

Model Number	89-7869
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility medwatch report ((b)(4)) was received on 06/09/2025 reporting no information provided other than the cautery pencil is underlined on the packaging form.The device did not do what it was supposed to do.The sample has not been returned to deroyal for evaluation at this time.A supplier corrective action request (scar) was issued to the pencil supplier covidien.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.
Event or Problem Description
No information provided other than the cautery pencil is underlined on the packaging form.The device did not do what it was supposed to do.
Additional Manufacturer Narrative
An user facility medwatch report ((b)(4)) was received on 06/09/2025 reporting no information provided other than the cautery pencil is underlined on the packaging form.The device did not do what it was supposed to do.Deroyal industries, inc.Requested return of the device, however, it was not able to be returned.Deroyal reviewed the work order for the device detailed in the complaint.No discrepancies or deviations were found within the manufacturing nor assembly process.Deroyal completed a complaint to sales ratio over the past two years and found it to be (b)(4), a supplier corrective action request (scar) was issued to the pencil supplier covidien.Covidien reviewed the device history record (dhr) and no abnormalities were found during the manufacturing process.Additionally no other complaints have been reported for this lot number.Root cause: because the device was not returned and no issues could be found within the manufacturing process, the root cause was unable to be determined.Corrective and preventive actions: because the root cause was unable to be determined, 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: ROBOTIC PACK
• 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: 22196030
• Report Number: 3005011024-2025-00007
• Device Sequence Number: 18452654
• Product Code: LRO
• UDI-Device Identifier: 00749756778688
• UDI-Public: 00749756778688
• Combination Product (Y/N): N
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: 89-7869
• Device Lot Number: 62196571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 08/07/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown