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

Catalog Number	PLP2020
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
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 the customer that the device, plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing, was being used on (b)(6) 2023 wnen the ¿cautery pencil was somehow activating the cut without depressing the button during dr's case.The surgical tech, was able to hear it being activated and noticed that it no one was touching it.It was luckily in the holster and immediately removed.The surgical tech said that even after she removed the pencil from the holster, the cut was still activating despite nothing touching the switch.The foot pedal was not in use and nothing was depressing the pedals.No harm was done to the patient or staff¿.The procedure was completed with an alternate same device.Further assessment has been sought but a response has not been received.Two lot numbers have been provided in connection with this complaint; it is unknown which lot number refers to the device at issue.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
A sales representative reported on behalf of the customer that the device, plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing, was being used on (b)(6) 2023 wnen the ¿cautery pencil was somehow activating the cut without depressing the button during dr's case.The surgical tech, was able to hear it being activated and noticed that it no one was touching it.It was luckily in the holster and immediately removed.The surgical tech said that even after she removed the pencil from the holster, the cut was still activating despite nothing touching the switch.The foot pedal was not in use and nothing was depressing the pedals.No harm was done to the patient or staff¿.The procedure was completed with an alternate same device.Further assessment has been sought but a response has not been received.Two lot numbers have been provided in connection with this complaint; it is unknown which lot number refers to the device at issue.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Device packaging was received but without the product; therefore, a device malfunction cannot be verified.If the device is returned at a later date, the investigation may be updated and reanalyzed.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 this is the only such occurrence for this lot number and failure mode.(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 EQUIPMENT CO; unit a, 11/f.mai wah ind bldg; 1-7 wah sing street; kwai chung, nt ; HK
• Manufacturer (Section G): MODERN MEDICAL EQUIPMENT CO; unit a, 11/f.mai wah ind bldg; 1-7 wah sing street; kwai chung, nt ; HK
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 18216459
• Report Number: 1320894-2023-00258
• Device Sequence Number: 6721764
• Product Code: GEI
• UDI-Device Identifier: 10845854061282
• UDI-Public: (01)10845854061282(17)250823(10)MM20220841
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K103375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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: 08/23/2025
• Device Catalogue Number: PLP2020
• Device Lot Number: MM20220841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic