MAUDE Adverse Event Report: MODERN MEDICAL EQUIP MFG LTD PLUMEPEN; 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	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the complaint investigation has not been completed.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A customer reported that the plp2520, elite surgical smoke evac pencil,7/8" (22mm),15ft.(4.6m) device was used in a procedure on approximately on (b)(6) 2025, and ¿bio-med reported durning surgery item: plp2520 activated electro surgery mode when not being touched (shorted out) item was being used with a lab ft10 system.Bio-med replicated the problem using same pen with different lab ft10.¿.The procedure was completed with the use of a ¿different pen used from same lot not issue¿ and a delay of 5 minutes.There was no impact to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Examination of returned device plp2520 found that the system 5000 would emit a sound and the coag button would light up immediately upon plugging the device in and without pressing any buttons.Examination was done with system 5000.Root cause cannot be determined, however, based upon evaluation of the device, risk documentation, and the ifu; a possible cause of this event could be tissue or fluid ingress into button site.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.(b)(4).Per the instructions for use, the user is advised to aspirate fluid from the area before activating the instrument.Conductive fluids (e.G., blood or saline) in direct contact with or in close proximity to an active electrode may carry electrical current or heat away from target tissues, which may cause unintended burns to the patient.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A customer reported that the plp2520, elite surgical smoke evac pencil,7/8" (22mm),15ft.(4.6m) device was used in a procedure on approximately 21mar25, and ¿bio-med reported durning surgery item plp2520 activated electro surgery mode when not being touched (shorted out) item was being used with a lab ft10 system.Bio-med replicated the problem using same pen with different lab ft10.¿.The procedure was completed with the use of a ¿different pen used from same lot not issue¿ and a delay of 5 minutes.There was no impact to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: PLUMEPEN
• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 21772865
• Report Number: 1320894-2025-00095
• Device Sequence Number: 12817179
• Product Code: GEI
• UDI-Device Identifier: 10845854061305
• UDI-Public: (01)10845854061305(17)250626(10)MM20220688
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K230547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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: 06/26/2025
• Device Catalogue Number: PLP2520
• Device Lot Number: MM20220688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FT10 SYSTEM; FT10 SYSTEM
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic