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

Catalog Number PLP2020

Device Problem Device Remains Activated (1525)

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

Event Date 09/15/2023

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

A distributor reported on behalf of the customer that the plp2020, plumepen elite surgical smoke evac pencil was being used during ¿spine surgery¿ on (b)(6) 2023, and the ¿electrocautery pencil switch stuck in on position during surgery¿.The procedure was completed with an unnamed alternate device and with a 15-minute delay.Follow-up assessment determined that the patient is "fine".There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Event Description

A distributor reported on behalf of the customer that the plp2020, plumepen elite surgical smoke evac pencil was being used during ¿spine surgery¿ on (b)(6) 2023 and the ¿electrocautery pencil switch stuck in on position during surgery¿.The procedure was completed with an unnamed alternate device and with a 15-minute delay.Follow-up assessment determined that the patient is "fine".There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The reported event ¿electrocautery pencil switch stuck in on position during surgery¿ was confirmed.No abnormalities or defects were confirmed upon visual inspection; however, upon further assessment of the inside components of the device, corrosion was witnessed.A likely cause of this issue is due to tissue or fluid ingress into the button site affecting button depression.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.(b)(4).We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 17896107
• MDR Text Key: 325252060
• Report Number: 1320894-2023-00202
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10845854061282
• UDI-Public: (01)10845854061282(17)250830(10)MM20220901
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• 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: MM20220901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic