MAUDE Adverse Event Report: WICKIMED PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY20; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	PLP2520
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	06/21/2023
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.Device not yet received.
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 open liver resection procedure on (b)(6) 2023 when it was reported, ¿fingerswitch diathermy standard power setting 60 tip melted away.The surgeon was actually harmed today and burnt his finger, this was also whilst cutting through abdominal muscle.¿.There was no report of medical intervention or hospitalization for the user or patient.The procedure was completed as planned.Further assessment questioning found that the surgeon sustained a 1st degree burn with no medical intervention or hospitalization.The procedure carried on as normal.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one plp2520 in original opened package.Lot number was verified.Performed a visual inspection, no abnormalities or defects were confirmed.Performed a functional inspection using the esu system 7550 (c8406), the device functioned as intended.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.(b)(4).Per the instructions for use, the user is advised the following: for procedures where visualization may be impaired, be alert of these potential hazards: the electrode tip may remain hot enough to cause burns after the current has been de-activated.Inadvertent activation or movement of the activated electrode outside of the field of vision may result in injury to the patient.Localized burns to the patient or physician may result from electrical currents carried through conductive objects.Current may be generated in conductive objects by direct contact with the active electrode, or by the active accessory being in close proximity to the conductive object.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 open liver resection procedure on (b)(6) 2023 when it was reported, ¿fingerswitch diathermy standard power setting 60 tip melted away.The surgeon was actually harmed today and burnt his finger, this was also whilst cutting through abdominal muscle.¿.There was no report of medical intervention or hospitalization for the user or patient.The procedure was completed as planned.Further assessment questioning found that the surgeon sustained a 1st degree burn with no medical intervention or hospitalization.The procedure carried on as normal.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY20
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): WICKIMED; 4-5/f, building b; tangjiao industrial area; lilin, huizhou, prc ; CH
• Manufacturer (Section G): WICKIMED; 4-5/f, building b; tangjiao industrial area; lilin, huizhou, prc ; CH
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 17315038
• Report Number: 1320894-2023-00137
• Device Sequence Number: 6095701
• Product Code: GEI
• UDI-Device Identifier: 10845854061305
• UDI-Public: (01)10845854061305(17)240525(10)520521
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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: 05/25/2024
• Device Catalogue Number: PLP2520
• Device Lot Number: 520521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic