MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. BODY LAP TRAY; GENERAL SURGERY TRAY

Model Number	89-4082
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary an internal complaint (call (b)(4)) was received indicating that a bovie tip contained within a convenience kit (part 89-4082, lot 53217385) malfunctioned during use.No patient injury was reported.The investigation is currently ongoing.When new and critical information is received, this report will be updated.
Event or Problem Description
The bovie tip contained in the convenience kit was defective.The surgeon was unable to control on/off.No injury to the patient reported.
Additional Manufacturer Narrative
A supplier corrective action request (scar) was issued to the bovie tip supplier covidien.Root cause: covidien was unable to determine the true root cause, due to lack of the sample.Corrective action: there were no corrective actions taken by covidien, because the root cause could not be determined.Per supplier covidien, the manufacturing records for each device are thoroughly reviewed to ensure the product meets its quality specifications.The 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: BODY LAP TRAY
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 11178181
• Report Number: 3005011024-2020-00008
• Device Sequence Number: 4086014
• Product Code: LRO
• UDI-Device Identifier: 00749756575812
• UDI-Public: 00749756575812
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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: 89-4082
• Device Lot Number: 53217385
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1