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

Catalog Number	PLPUL2020
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales representative reported on behalf of the customer that the device, plpul2020, ultra surgical smoke evacuation pencil, was being used during an unknown procedure on (b)(6) 2025 when it was reported, ¿the inner piece cracked and pieces broke off and had to be located inside the patient.¿.An alternate same device was used to complete the procedure causing a delay of unknown minutes.There was no report of injury, medical intervention, or hospitalization for the patient.The patient¿s status was reported as ¿good¿.A good faith effort was conducted by conmed to determine if all fragmentation had been retrieved; however, to date we have not received a response.This report is being raised due to the reported injury of possible foreign body left in 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.
Additional Manufacturer Narrative
The device has not been returned to date and no photographic evidence was provided.Therefore, the reported event can not 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 17 complaints, regarding 32 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 per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, plpul2020, ultra surgical smoke evacuation pencil, was being used during an unknown procedure on (b)(6) 2025 when it was reported, ¿the inner piece cracked and pieces broke off and had to be located inside the patient.¿.An alternate same device was used to complete the procedure causing a delay of unknown minutes.There was no report of injury, medical intervention, or hospitalization for the patient.The patient¿s status was reported as ¿good¿.A good faith effort was conducted by conmed to determine if all fragmentation had been retrieved; however, to date we have not received a response.This report is being raised due to the reported injury of possible foreign body left in patient.

• 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: 22182856
• Report Number: 1320894-2025-00152
• Device Sequence Number: 18315543
• Product Code: GEI
• UDI-Device Identifier: 20845854061210
• UDI-Public: (01)20845854061210(17)270928(10)WM20240955
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 07/21/2025

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: PLPUL2020
• Device Lot Number: WM20240955
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2024
• 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