MAUDE Adverse Event Report: MODERN MEDICAL EQUIP MFG LTD PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY20; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number PLP2520

Device Problem Self-Activation or Keying (1557)

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

Event Date 02/08/2024

Event Type  malfunction  

Event Description

This complaint was created due to the receipt of a medwatch report (b)(4) on 23feb24.The report was found to be written against plp2520, plumepen elite surgical smoke evac pencil, that was being used during an unknown procedure on (b)(6) 2024.The report stated, ¿during surgical procedure, the cautery button remained depressed and noted to be defective.The device was sequestered.This is the third or fourth of these events that have occurred recently in our or.¿ the procedure was completed and there was no report of injury, medical intervention or extended hospitalization for the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

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.

Manufacturer Narrative

The device will not be returned and no photographic evidence was provided therefore, a device malfunction cannot 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.(b)(4).We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

This complaint was created due to the receipt of a medwatch report 0700280000-2024-8008 on (b)(6) 24.The report was found to be written against plp2520, plumepen elite surgical smoke evac pencil, that was being used during an unknown procedure on (b)(6) 24.The report stated, ¿during surgical procedure, the cautery button remained depressed and noted to be defective.The device was sequestered.This is the third or fourth of these events that have occurred recently in our or.¿.The procedure was completed and there was no report of injury, medical intervention or extended hospitalization for the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY20
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MODERN MEDICAL EQUIP MFG LTD; unit a, 10/f mai wah ind bldg; 1-7 wah sing street; kwai chung, nt, ; HK
• Manufacturer (Section G): MODERN MEDICAL EQUIP MFG LTD; unit a, 10/f mai wah ind bldg; 1-7 wah sing street; kwai chung, nt ; HK
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 18904926
• MDR Text Key: 337761638
• Report Number: 1320894-2024-00063
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10845854061305
• UDI-Public: (01)10845854061305(17)250626(10)MM20220688
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K230547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

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: PLP2520
• Device Lot Number: MM20220688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 40 KG
• Patient Ethnicity: Non Hispanic