MAUDE Adverse Event Report: MODERN MEDICAL EQUIPMENT ELECTRODE , BLADE 1" COATED, ENT MODIFIED; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	88-000M13C
Medical Device Problem Codes	Component or Accessory Incompatibility (2897); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "the fit of the tip to our cautery handpiece is not secured.Moreover, the insulation balloons up during the procedure which is unsafe." deroyal requested the sample to be returned, however it was unavailable.A supplier corrective action request (scar) will be sent to the 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 when additional information becomes available.
Event or Problem Description
A user facility reported, "the fit of the tip to our cautery handpiece is not secured.Moreover, the insulation balloons up during the procedure which is unsafe.".
Additional Manufacturer Narrative
The item was not available for return and no lot number was provided.Deroyal reviewed failure mode effect analysis (fmea) and did not find any issues.A complaint to sales ratio was calculated from august 2021 to november 2023 and found to be (b)(4).A supplier corrective action request (scar) was sent to the supplier modern medical equipment.Root cause: because a sample could not be returned and no key usage information was provided, the cause was not able to be established.Corrective and preventive actions: no corrective or preventive actions were taken because the root cause could not be established.Deroyal will continue to monitor for trends for this product 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.

• Brand Name: ELECTRODE , BLADE 1" COATED, ENT MODIFIED
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & 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
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19950643
• Report Number: 1060680-2023-00009
• Device Sequence Number: 15667652
• Product Code: GEI
• UDI-Device Identifier: 00749756136013
• UDI-Public: 00749756136013
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K023986
• 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): 11/07/2023

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: 88-000M13C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown