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	Device Remains Activated (1525)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales representative reported on behalf of the customer, that the plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing was being used during a total knee replacement procedure on 08dec23 when it was reported ¿it was "using a plumepen elite and the buttons stuck and did not turn off.Ended up burning the patient multiple times.¿.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.The procedure was completed without the use of an alternate device, and the current status of the patient was reported as ¿doing ok but does have burns on them.¿.There was no report of medical intervention or extended hospitalization to the patient or user.This report is being raised on reported injury due to the unknown degree of patient burn.
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.H3 other text : device not yet received.
Event or Problem Description
The sales representative reported on behalf of the customer, that the plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing was being used during a total knee replacement procedure on 08dec23 when it was reported ¿it was "using a plumepen elite and the buttons stuck and did not turn off.Ended up burning the patient multiple times.¿.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.The procedure was completed without the use of an alternate device, and the current status of the patient was reported as ¿doing ok but does have burns on them.¿.There was no report of medical intervention or extended hospitalization to the patient or user.This report is being raised on reported injury due to the unknown degree of patient burn.
Additional Manufacturer Narrative
The device has not been returned to date and no photographic evidence was provided.Therefore, the reported event cannot be verified.A two-year lot history review shows this is the only event for this lot number and failure mode.A device history record 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 16 complaints, regarding 16 devices, for this device family and failure mode.During this same time frame 4,369,140 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 0.000004.Per the instructions for use, the user is advised to place active accessories in a holster or in a clean, dry, non-conductive and highly visible area away from the patient when not in use.Inadvertent contact with the patient may result in burns.The electrode tip may remain hot enough to cause burns after the current has been de-activated.The plumepen elite is a monopolar electrode, the use of a dispersive electrode is required to prevent burns/injury to patient.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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 18448767
• Report Number: 1320894-2024-00004
• Device Sequence Number: 20724705
• Product Code: GEI
• UDI-Device Identifier: 10845854061282
• UDI-Public: (01)10845854061282(17)251106(10)MM20221113
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/06/2025
• Device Catalogue Number: PLP2020
• Device Lot Number: MM20221113
• 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: 12/11/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic