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

Model Number	89-2580
Medical Device Problem Codes	Smoking (1585); Sparking (2595)
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.
Additional Manufacturer Narrative
An initial complaint was received on 12/15/2023 reporting bovie @ 30/30 sparking on instrument producing a lot of smoke.A user facility medwatch report (#4400150000-2023-8089) was received on 1/4/2024 stating sparking in the patient causing lots of smoke.The sample has not been returned to deroyal for evaluation at this time.A supplier corrective action request (scar) was issued to the handcontrol 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.
Additional Manufacturer Narrative
An initial complaint was received on 12/15/2023 reporting bovie @ 30/30 sparking on instrument producing a lot of smoke.The user facility medwatch report (#: (b)(4) was received on 1/4/2024 stating sparking in the patient causing lots of smoke.The sample was returned for evaluation.A supplier corrective action request (scar) was issued to the hand control pencil supplier covidien.The root cause of the reported issue was unable to be determined by the supplier covidien.Based on the evidence available, the reported condition of arcing / sparking, was not confirmed.This report is based on information provided by product analysis (pa) personnel.Pa received one e2450hnsb for evaluation.The sample did meet specifications as received.The visual inspection found no notable conditions.The troubleshooting found the pencil had no visual defects.When the electrode was inserted, it stayed in place and was not loose.The switch resistance was a bit on the high side, and a little inconsistent.The pencil did not self-activate.The pencil button activation force was within the specification.The pencil functioned normally when activated in the generator.The electrode insertion/extraction was within the specification.The pencil passed hipot testing.Due to the root cause determination, there were no corrective and preventive actions taken by the supplier covidien.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: SMALL GENERAL 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: 18464102
• Report Number: 3005011024-2024-00002
• Device Sequence Number: 12541861
• Product Code: LRO
• UDI-Device Identifier: 00749756281416
• UDI-Public: 00749756281416
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/06/2024

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: 89-2580
• Device Lot Number: 59960381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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