MAUDE Adverse Event Report: MODERN MEDICAL EQUIP MFG LTD PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	PLP2020
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Conmed japan reported on behalf of the customer that the plp2020 - plumepen elite surgical smoke evac pencil, 10ft tubing, qty20, was being used (b)(6) 2024 and the "output did not work well¿.It was reported that this event occurred during surgery with no impact to the patient.The device evaluation revealed that "the coagulation continuously activates without pressing the button.".This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one plp2020 in opened original packaging.Lot number was verified.Performed a visual inspection, the coagulation button within the handpiece is concaved making continuous contact with the circuit board.Performed a functional inspection using the esu system 7550, the coagulation continuously activates without pressing the button.The root cause cannot be determined; however, based upon evaluation, risk documentation, and photos, the likely cause of this event was electrical shorting due to water ingression into the device.A two-year lot history review shows a total of 1 device for this lot number and failure mode.A device history record (dhr) review was requested from the manufacturer, and no indication of abnormalities was communicated.A two-year review of complaint history revealed there has been a total of 10 reports, regarding 10 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MODERN MEDICAL EQUIP MFG LTD; unit a, 10/f mai wah ind bldg; 1-7 wah sing street; kwai chung, nt ; HK
• Manufacturer (Section G): MODERN MEDICAL EQUIP MFG LTD; unit a, 10/f mai wah ind bldg; 1-7 wah sing street; kwai chung, nt ; HK
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 19267672
• Report Number: 1320894-2024-00123
• Device Sequence Number: 12620001
• Product Code: GEI
• UDI-Device Identifier: 10845854061282
• UDI-Public: (01)10845854061282(17)251223(10)MM20221214
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K230547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/23/2025
• Device Catalogue Number: PLP2020
• Device Lot Number: MM20221214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic