MAUDE Adverse Event Report: MODERN MEDICAL EQUIP MFG LTD PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number PLP2020

Device Problem No Device Output (1435)

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

Event Date 01/09/2024

Event Type  malfunction  

Manufacturer Narrative

Received one plp2020 in opened original package.Lot number was not verified.Performed a visual inspection, no abnormalities or defects were confirmed.Performed a functional inspection using the esu system, the complaint was confirmed.The device automatically activated coag when plugged into the esu unit.When investigating further into the electrical circuit board, there was evidence of corrosion which could potentially cause the failure mode.A root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be tissue or fluid ingress into button site affects 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.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 68 complaints, regarding 116 devices, for this device family and failure mode.During this same time frame 4,315,600 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 0.00003.Per the instructions for use, the user is advised the following: keep the active electrodes clean.Build-up of eschar may reduce the instrument¿s effectiveness.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

It was reported by the customer that the ¿plp2020 - plumepen elite surgical smoke evac pencil, 10ft tubing,qty20, "that the coag button was broken so that output could not be used.¿.It was reported that this event occurred during surgery with no impact to patient.However, during evaluation of the device it was discovered that the device self-activated when plugged into the esu.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 18928586
• MDR Text Key: 337965469
• Report Number: 1320894-2024-00069
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10845854061282
• UDI-Public: (01)10845854061282(17)250527(10)MM20220634
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K230547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• 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: MM20220634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic