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
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1320894-2024-00063
• Device Sequence Number: 15720521
• Product Code: GEI
• UDI-Device Identifier: 10845854061305
• UDI-Public: (01)10845854061305(17)250626(10)MM20220688
• 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
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2025
• Device Catalogue Number: PLP2520
• Device Lot Number: MM20220688
• 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: 02/23/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 40 KG
• Patient Ethnicity: Non Hispanic