MAUDE Adverse Event Report: MODERN MEDICAL EQUIPMENT ELECTRODE, NEEDLE 1" COATED, ENT MODIFIED; ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Model Number	88-000M12C
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Deroyal industries requested return of the product, but it was not available for return.Deroyal industries reviewed work orders and corrective actions and preventive actions (capas) and did not find any discrepancies.A complaint to sales ratio and found that it was 0.00005 or 0.005%.The supplier corrective action request (scar) was returned from modern medical equipment.Root cause: after investigation, modern medical equipment stated that the single electrode does not cause liquid inflow and therefore would not cause fluid to flow into the pen.Because the device could not be returned and there was limited information provided about the surgery, the root cause was unable to be determined.Corrective or preventative actions: because no root cause could be established, no corrective or preventative actions were taken.Deroyal will continue to monitor for trends around the issue and item.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if more information becomes available.
Event or Problem Description
A new customer complain about our electrode.We went to speak with the surgeon and he told us when the blood enters through the hole where the electrode is inserted in the handle and when the blood or liquid comes out again it burns the patient.
Additional Manufacturer Narrative
A user facility reported, " a new customer complain about our electrode.We went to speak with the surgeon and he told us when the blood enters through the hole where the electrode is inserted in the handle and when the blood or liquid comes out again it burns the patient." deroyal industries requested return of the product, but it was not available for return.A supplier corrective action request (scar) will be issued to the electrode supplier modern medical equipment.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once more information is available.

• Brand Name: ELECTRODE, NEEDLE 1" COATED, ENT MODIFIED
• Common Device Name: ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): MODERN MEDICAL EQUIPMENT; unit a, 10/f; mai wah ind.; bldg 1-7 wah sing street; kwai chung, new territories ; HK
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell, tn 37825 ; HK 37825
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849
• MDR Report Key: 19941301
• Report Number: 1060680-2023-00005
• Device Sequence Number: 12592488
• Product Code: HGI
• UDI-Device Identifier: 50749756135998
• UDI-Public: 50749756135998
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K952030
• 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): 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 88-000M12C
• Device Lot Number: 58466647
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown