MAUDE Adverse Event Report: MODERN MEDICAL EQUIPMENT CO. PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY20; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	PLP2520
Medical Device Problem Code	Self-Activation or Keying (1557)
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 plp2520, plumepen elite surgical smoke evac pencil, 15ft tubing,qty20 device was being used during a removal spine hardware procedure on (b)(6) 2024, and ¿cautery pencil remained active even when buttons not pushed.Scrub tech noticed the high pitch noise the cautery machine makes and was made awre that the machine was activated.Surgeon went to use the cautery at the same time and noticed it was already activated prior to him puching the button.This cautery pencil did not come inside the spine pack.It was pulled from the supply shelf.¿.The procedure was completed with a second elite 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 device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, the reported event cannot be verified.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.This is the only such occurrence for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 44 reports, regarding 66 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.
Event or Problem Description
A sales representative reported on behalf of a customer that the plp2520, plumepen elite surgical smoke evac pencil, 15ft tubing,qty20 device was being used during a removal spine hardware procedure on (b)(6) 2024, and ¿cautery pencil remained active even when buttons not pushed.Scrub tech noticed the high pitch noise the cautery machine makes and was made awre that the machine was activated.Surgeon went to use the cautery at the same time and noticed it was already activated prior to him puching the button.This cautery pencil did not come inside the spine pack.It was pulled from the supply shelf¿.The procedure was completed with a second elite 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.

• Brand Name: PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY20
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MODERN MEDICAL EQUIPMENT CO.; unit a, 11/f.mai wah ind bldg; 1-7 wah sing street; kwai chung, nt 13502 ; HK 13502
• 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: beth madeline ; 11311 concept blvd; largo, FL ; 7274708358
• MDR Report Key: 18889219
• Report Number: 1320894-2024-00062
• Device Sequence Number: 11512580
• Product Code: GEI
• UDI-Device Identifier: 10845854061305
• UDI-Public: (01)10845854061305(17)251031(10)MM20221101
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K230547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

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: 10/31/2025
• Device Catalogue Number: PLP2520
• Device Lot Number: MM20221101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic