MAUDE Adverse Event Report: WICKIMED PLUMEPEN ULTRA SURGICAL SMOKE EVACUATION PENCIL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number PLPUL2520

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2023

Event Type  malfunction  

Event Description

The sales representative reported on behalf of the customer that the plpul2520, plumepen ultra surgical smoke evacuation pencil was being used on (b)(6) 2023 during a wide local excision of melanoma and the ¿surgeon was using the ultra pencil and the cam lock broke while surgeon was pressing down with the bovie.The cam lock broke into big pieces and was quickly removed from patient.The surgeon was not upset and the patient was safe.No harm was done.It might have been a user error of pressing on the plastic cam lock too hard.¿.There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.The procedure was completed with an alternate unknown device, and it is not known if there was a delay.This report is being raised due to 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.A two-year lot history review cannot be conducted as a lot number was not provided.A device history record review cannot be conducted as a lot number was not provided.A two-year review of complaint history revealed there has been a total of 36 reports, regarding 51 devices, for this device family and failure mode.During this same time frame 4,045,920 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 0.00001.Per the instructions for use, the user is advised the following: if necessary to remove blade, 6a.Unplug the pencil 6b.Ensure that cam is in the lock position 6c.Use a surgical clamp and pull blade forward 6d.Replace with blade of choice6e.Confirm that blade is completely inserted and secure before activating pencil.Never force the blade into the pencil.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: PLUMEPEN ULTRA SURGICAL SMOKE EVACUATION PENCIL
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): WICKIMED; 4-5/f, building b; tangjiao industrial area; lilin, huizhou 51600 0; CH 516000
• Manufacturer (Section G): WICKIMED; 4-5/f, building b; tangjiao industrial area; lilin, huizhou 51600 0; CH 516000
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 17641423
• MDR Text Key: 322161951
• Report Number: 1320894-2023-00167
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: PLPUL2520
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic