MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL SMALL GENERAL PACK; GENERAL SURGERY TRAY

Model Number	89-2580
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Sparking in the patient causing lots of smoke.

• Brand Name: DEROYAL SMALL GENERAL PACK
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk ln.; powell TN 37849
• MDR Report Key: 18442947
• Report Number: 18442947
• Device Sequence Number: 8114308
• Product Code: LRO
• UDI-Device Identifier: 00749756281416
• UDI-Public: (01)00749756281416
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/15/2023
• Report Date (Section F): 12/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: 89-2580
• Device Lot Number: 59960381
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 99 KG
• Patient Race: White
• Date Report Sent to FDA: 12/15/2023