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

Device Problem Device Remains Activated (1525)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 09/06/2023

Event Type  Injury  

Event Description

The sales representative reported on behalf of the customer that the plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing,qty20, was being used during a total joint procedure on (b)(6) 2023 when it was reported, ¿the electrode of the device remained active in the surgeon's hands after he let his finger off the switch.The electrode came in contact with the pt's skin and caused a burn.¿.There was no report of hospitalization for the patient and the procedure was completed.Further assessment questioning found that the patient sustained a 3rd degree burn that required medical intervention; however, the type of intervention was not reported.The patient was discharged home.This report is being raised due to the reported injury for 3rd degree of burn to the patient.

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.

Manufacturer Narrative

The electrode came in contact with the pt's skin and caused a burn¿ was confirmed.Received one plp2020 in opened original packaging.Lot number was verified.Performed a visual inspection, the coagulation button is stuck in the downward position within the handpiece creating continuous contact with the circuit board.Performed a functional inspection using the system 5000 (c5731), the coagulation continuously activates.A likely cause of this issue is due to tissue or fluid ingress into the button site affecting button depression.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 complaint 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 (b)(4) complaints, regarding (b)(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).A determination for further investigation has been initiated.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing,qty20, was being used during a total joint procedure on (b)(6) 2023 when it was reported, ¿the electrode of the device remained active in the surgeon's hands after he let his finger off the switch.The electrode came in contact with the pt's skin and caused a burn.¿.There was no report of hospitalization for the patient and the procedure was completed.Further assessment questioning found that the patient sustained a 3rd degree burn that required medical intervention; however, the type of intervention was not reported.The patient was discharged home.This report is being raised due to the reported injury for 3rd degree of burn to the patient.

• Brand Name: PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20
• Type of Device: 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 17825637
• MDR Text Key: 324368392
• Report Number: 1320894-2023-00194
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10845854061282
• UDI-Public: (01)10845854061282(17)250920(10)MM20220941
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: PLP2020
• Device Lot Number: MM20220941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 09/27/2023
• Supplement Dates Manufacturer Received: 10/25/2023
• Supplement Dates FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Ethnicity: Non Hispanic