MAUDE Adverse Event Report: MODERN MEDICAL EQUIP MFG LTD 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	Burn(s) (1757)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The sales representative reported on behalf of the customer that the plp2520, plumepen elite surgical smoke evac pencil, 15ft tubing,qty20, was being used during a spine fusion procedure on (b)(6) 2024 when it was reported, ¿during a scheduled procedures the cords to the equipment were thrown off the sterile field to be plugged in.The bovie was plugged into the cautery machine.When the rn went to plug the drill in his finger on his left hand was burned.The bovie was in the on setting without the button being pushed by the surgeon.The bovie tip was in contact with the drill at the time it was being plugged in.This case was using neuromonitoring.When the bovie is on, neuromonitoring can pick up the electricity on their machine.They noticed there was a lot of artifacts on their machine and asked the nurse to check the cautery.This is when he went to plug in the drill and burnt his hand on the plug in.When cautery was unplugged the artifact on the neuromonitoring subsided.".There was no report of medical intervention or hospitalization for the user.Further assessment questioning found that the report advised, ¿the woman¿s finger was red, but it was not a serious burn.¿ this report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer that the plp2520, plumepen elite surgical smoke evac pencil, 15ft tubing, (b)(4), was being used during a spine fusion procedure on 14feb24 when it was reported, ¿during a scheduled procedures the cords to the equipment were thrown off the sterile field to be plugged in.The bovie was plugged into the cautery machine.When the rn went to plug the drill in his finger on his left hand was burned.The bovie was in the on setting without the button being pushed by the surgeon.The bovie tip was in contact with the drill at the time it was being plugged in.This case was using neuromonitoring.When the bovie is on, neuromonitoring can pick up the electricity on their machine.They noticed there was a lot of artifacts on their machine and asked the nurse to check the cautery.This is when he went to plug in the drill and burnt his hand on the plug in.When cautery was unplugged the artifact on the neuromonitoring subsided." there was no report of medical intervention or hospitalization for the user.Further assessment questioning found that the report advised, ¿the woman¿s finger was red, but it was not a serious burn.¿ this report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction 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 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 20 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).We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 18920402
• Report Number: 1320894-2024-00067
• Device Sequence Number: 14985164
• Product Code: GEI
• UDI-Device Identifier: 10845854061305
• UDI-Public: (01)10845854061305(17)251103(10)MM20221106
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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: 11/03/2025
• Device Catalogue Number: PLP2520
• Device Lot Number: MM20221106
• 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: 03/27/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic