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	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A sales representative reported on behalf of a customer that the plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing,qty20 device was being used during an unnamed procedure on (b)(6) 2024, and ¿cautery had flames coming out of the tip when the surgeon tried to cauterize an artery on a hematoma.Patient was not harmed.Immediately discontinued use of the cautery and used a new one.¿.The procedure was completed with a ¿different pencil¿ and no reported delay.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing,qty20 device was being used during an unnamed procedure on (b)(6) 2024, and ¿cautery had flames coming out of the tip when the surgeon tried to cauterize an artery on a hematoma.Patient was not harmed.Immediately discontinued use of the cautery and used a new one.¿.The procedure was completed with a ¿different pencil¿ and no reported delay.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received two plp2020 in opened original package.Lot number was verified.Performed a visual inspection, no abnormalities or defects were confirmed.Performed a functional inspection using the esu system 7550 (c8406).The device functioned as intended with no abnormalities noted.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.A two-year lot history review shows a total of two (2) devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 4 reports, regarding 4 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).Per the instructions for use, the user is advised to not use electrosurgery in the presence of flammable anesthetics or other flammable gases, fluids, or objects, or in the presence of oxidizing agents, as fire may result.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 13502 ; HK 13502
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 18905397
• Report Number: 1320894-2024-00064
• Device Sequence Number: 7887374
• Product Code: GEI
• UDI-Device Identifier: 10845854061282
• UDI-Public: (01)10845854061282(17)250804(10)MM20220812
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 05/07/2024

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: 08/04/2025
• Device Catalogue Number: PLP2020
• Device Lot Number: MM20220812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic