MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. PLASTIC PROCEDURE; GENERAL SURGERY TRAY

Model Number	89-2575
Medical Device Problem Codes	Continuous Firing (1123); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: a medwatch report (uf/importer report #4400150000-2020-8027) was received indicating that a cautery pencil contained within a convenience kit (part 89-2575, lot 52183443) malfunctioned during use.Initially, a sample was reported to be available for return.As of the date of this report, that sample has not been returned for evaluation.A review of the bill of materials (bom) identified that the affected kit component was 5-19017, a push button cautery pencil.This raw material is supplied to deroyal by covidien.The work order was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.The supplier corrective action request (scar) log was reviewed to determine if similar issues have been reported previously.There have been previous reported issues for the same raw material.Therefore, a scar was issued to covidien and is due 10/30/2020.As of the date of this report, a response has not been received.A raw material inspection of the available lots in inventory was conducted.No raw material was found to be defective.The investigation is ongoing at this time.When new and critical information becomes available, this report will be updated.
Event or Problem Description
The cautery pencil was plugged into an ft10 unit.The surgeon activated the pencil, and released the button.After releasing the button, the pencil continued to operate.The pencil continued to malfunction after being switched from monopolar 1 to monopolar 2.Eventually, it was switched out with a different product.The cautery pencil was packaged in a convenience kit.
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: PLASTIC PROCEDURE
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 10684756
• Report Number: 3005011024-2020-00004
• Device Sequence Number: 10905534
• Product Code: LRO
• UDI-Device Identifier: 00749756281379
• UDI-Public: 00749756281379
• 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: 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: 89-2575
• Device Lot Number: 51283443
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/15/2020
• 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
• Patient Age: 41 YR
• Patient Weight: 65