MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L E.S. PENCIL,PUSHBUTTON, WITH HOLSTER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	88-000002
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "our facility uses your bovie pencils, ref# 88-000002, and we had an issue during a total knee replacement this morning.The bovie's "cut" activated on its own and stayed activated.This has happened in the past but the pencil and pad were not saved from the previous incident.Our bovie machine was inspected and cleared from the previous incident.After today's incident, the bovie was switched with a different brand and the issue was not duplicated.The defective bovie was re-inserted and it activated without the pencil being pushed.The lot number of this bovie is 58744504.We have preserved the bovie pencil and cautery tip for further inspection." the electrosurgical pencil was requested for return, however the device was not returned.Deroyal industries reviewed device history records and failure modes and effects analysis (fmea) and no issues were found.Work orders of the sub-assemblies that made up the electrosurgical pencil were reviewed and it was confirmed that no issues were identified during a continuity test.Product that was in process was also inspected and no similar issues were identified.Complaint to sales ratio was calculated over the last two years to be (b)(4).Root cause: because the device was not returned and no issues were found in the investigation, no root cause could be determined.Corrective and preventive action: because no issue or root cause were established, 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.
Event or Problem Description
A user facility reported, "our facility uses your bovie pencils, ref# 88-000002, and we had an issue during a total knee replacement this morning.The bovie's "cut" activated on its own and stayed activated.This has happened in the past but the pencil and pad were not saved from the previous incident.Our bovie machine was inspected and cleared from the previous incident.After today's incident, the bovie was switched with a different brand and the issue was not duplicated.The defective bovie was re-inserted and it activated without the pencil being pushed.The lot number of this bovie is 58744504.We have preserved the bovie pencil and cautery tip for further inspection.".

• Brand Name: E.S. PENCIL,PUSHBUTTON, WITH HOLSTER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park, p.o. box 180-3006; 602 parkway,; la aurora, heredia 146 ; CS 146
• Manufacturer (Section G): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park, p.o. box 180-3006; 602 parkway,; la aurora, heredia 146 ; CS 146
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19951318
• Report Number: 9613793-2023-00017
• Device Sequence Number: 8923818
• Product Code: GEI
• UDI-Device Identifier: 00749756053280
• UDI-Public: 00749756053280
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K940909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2023

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: 88-000002
• Device Lot Number: 58744504
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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