MAUDE Adverse Event Report: WICKIMED PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number PLP2020

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 11/23/2023

Event Type  malfunction  

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 Description

The customer reported that the plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing was being used during a cervical conization on 23nov23 when it was reported ¿during the use one operator had a slight burn and the second operator felt an electric shock on contact with the colleague.¿.Further assessment found that the operator did obtain a 1st degree burn on her arm.It was also reported that "had a slight burn (probably she wanted to see the elite handpiece aspiration and she touched the patient)".Nothing was used to treat the burn.It was also confirmed that the second user was not diagnosed with a burn and was not injured, the procedure was completed and the current status of the users are ¿well¿.Furthermore, it was confirmed that a plp2020 handpiece caused the incident not the 60-2450-230, system 2450, 230v.The system 2450 will be listed as a concomitant device and no allegation will be written against it.This report shall be written against the first operator obtaining a 1st degree burn.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.(b)(4).Per the instructions for use, the user is advised do not activate the instrument when not in contact with target tissue, as this may cause injuries due to capacitive coupling.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The customer reported that the plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing was being used during a cervical conization on (b)(6) 2023 when it was reported ¿during the use one operator had a slight burn and the second operator felt an electric shock on contact with the colleague.¿.Further assessment found that the operator did obtain a 1st degree burn on her arm.It was also reported that "had a slight burn (probably she wanted to see the elite handpiece aspiration and she touched the patient)".Nothing was used to treat the burn.It was also confirmed that the second user was not diagnosed with a burn and was not injured, the procedure was completed and the current status of the users are ¿well¿.Furthermore, it was confirmed that a plp2020 handpiece caused the incident not the 60-2450-230, system 2450, 230v.The system 2450 will be listed as a concomitant device and no allegation will be written against it.This report shall be written against the first operator obtaining a 1st degree burn.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): WICKIMED; 4-5/f, building b; tangjiao industrial area; lilin, huizhou, prc 51600 0; CH 516000
• Manufacturer (Section G): WICKIMED; 4-5/f, building b; tangjiao industrial area; lilin, huizhou, prc 51600 0; CH 516000
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 18436942
• MDR Text Key: 332615132
• Report Number: 1320894-2024-00002
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K230547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PLP2020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: 60-2450-230, SYSTEM 2450, 230V.; 60-2450-230, SYSTEM 2450, 230V.
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic