MAUDE Adverse Event Report: WICKIMED PLUMEPEN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	PLPUL2520
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales representative reported on behalf of the customer that the device, plpul2520, ultra surgical smoke evacuation pencil, was being used during an open-heart procedure on (b)(6) 2025 when it was reported, ¿blade and housing broke off and into the smoke capture port.¿.An alternate same device was used to complete the procedure causing a delay of 5-minutes.There was no report of injury, medical intervention, or hospitalization for the patient.There was no report of device being in contact with the patient at the time of the malfunction.A good faith effort was conducted by conmed to assure no fragmentation came into contact with the patient; however, to date we have not received a response.This report is being raised due to the reported injury of unknown fragmentation contact to the patient.
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 per regulatory requirements to help ensure patient safety.Device not yet received.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, (b)(6), ultra surgical smoke evacuation pencil, was being used during an open-heart procedure on (b)(6) 2025 when it was reported, ¿blade and housing broke off and into the smoke capture port.¿.An alternate same device was used to complete the procedure causing a delay of 5-minutes.There was no report of injury, medical intervention, or hospitalization for the patient.There was no report of device being in contact with the patient at the time of the malfunction.A good faith effort was conducted by conmed to assure no fragmentation came into contact with the patient; however, to date we have not received a response.This report is being raised due to the reported injury of unknown fragmentation contact to the patient.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event cannot be verified.A device history record (dhr) review was requested from the manufacturer, and no indication of abnormalities was communicated.A two-year lot history review shows a total of 2 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 31 complaints, regarding 35 devices, for this device family and failure mode.During this same time frame 5,839,463 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 0.000006.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: PLUMEPEN
• Common Device Name: 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 22182858
• Report Number: 1320894-2025-00153
• Device Sequence Number: 18315544
• Product Code: GEI
• UDI-Device Identifier: 20845854061227
• UDI-Public: (01)20845854061227(17)271025(10)WM20241053
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K230547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PLPUL2520
• Device Lot Number: WM20241053
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2024
• 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