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	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The sales representative reported on behalf of the customer, that the plp2520 plumepen elite surgical smoke evac pencil, 15ft tubing, qty20 was being used during an unknown procedure on (b)(6) 2024 date when it was reported the button broke on the pencil causing it to remain on, no injury.¿.There was no report of injury, medical intervention or extended hospitalization to the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction: b3 updated event date from 08feb24 to 30jan24.Received one plp2520 in opened original packaging.Lot number was verified.Performed a visual inspection, the coagulation button is concaved causing continuous connection to the circuit board.Performed a functional inspection using the esu system 7550 (c8406), the device continuously activates.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.A two-year lot history review shows a total of 2 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 44 complaints, regarding 66 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 for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer, that the plp2520 plumepen elite surgical smoke evac pencil, 15ft tubing, qty20 was being used during an unknown procedure on (b)(6) 2024 date when it was reported the button broke on the pencil causing it to remain on, no injury.¿.There was no report of injury, medical intervention or extended hospitalization to the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one plp2520 in opened original packaging.Lot number was verified.Performed a visual inspection, the coagulation button is concaved causing continuous connection to the circuit board.Performed a functional inspection using the esu system 7550 (c8406), the device continuously activates.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.A two-year lot history review shows a total of (b)(4)devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding (b)(4) 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 for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer, that the plp2520 plumepen elite surgical smoke evac pencil, 15ft tubing, qty (b)(4) was being used during an unknown procedure on 08feb24 date when it was reported the button broke on the pencil causing it to remain on, no injury.There was no report of injury, medical intervention or extended hospitalization to 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: 18844666
• Report Number: 1320894-2024-00051
• Device Sequence Number: 7832326
• Product Code: GEI
• UDI-Device Identifier: 10845854061305
• UDI-Public: (01)10845854061305(17)250925(10)MM20220949
• 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,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2024

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: 09/25/2025
• Device Catalogue Number: PLP2520
• Device Lot Number: MM20220949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 03/19/2024; 03/19/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 03/29/2024; 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic