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

Catalog Number PLP2020

Device Problems Melted (1385); Excessive Heating (4030)

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

Event Date 03/03/2022

Event Type  malfunction  

Event Description

The sales representative reported on behalf of the customer that the plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing,qty20, was being used during an exploratory laparotomy on (b)(6) 2022 when it was reported, ¿one of their plumepen elite smoke evacuation pencils got very hot during a case.It was so hot that it melted the smoke evacuation port on the pen and burnt through the surgeon's glove.The heat was highest of the end of the electrode where the insulation is closest to where the electrode attaches to the pen.¿ there was no report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed using another plumepen elite with no report of delay.Further assessment questioning found that the customer was using the device connected to a megadyne esu that was purchased on (b)(6) 2015, the esu was set on 30/30 and they were using a megadyne grounding pad.The megadyne esu and the megadyne grounding pad will be listed as concomitant devices.It was also stated that ¿the surgeon did not receive a burn, the surgeon is fine, no long-term damage/injury.The patient had about 5 lbs of fluid in her abdomen.The surgeon did not notice the pen was burning until one of his circulating nurses smelled a ¿burning plastic¿ smell.¿ this report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Manufacturer narrative: the sales representative reported on behalf of the customer that the plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing,qty20, was being used during an exploratory laparotomy on (b)(6) 2022 when it was reported, ¿one of their plumepen elite smoke evacuation pencils got very hot during a case.It was so hot that it melted the smoke evacuation port on the pen and burnt through the surgeon's glove.The heat was highest of the end of the electrode where the insulation is closest to where the electrode attaches to the pen.¿ there was no report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed using another plumepen elite with no report of delay.Further assessment questioning found that the customer was using the device connected to a megadyne esu that was purchased on 12/23/15, the esu was set on 30/30 and they were using a megadyne grounding pad.The megadyne esu and the megadyne grounding pad will be listed as concomitant devices.It was also stated that ¿the surgeon did not receive a burn, the surgeon is fine, no long-term damage/injury.The patient had about 5 lbs of fluid in her abdomen.The surgeon did not notice the pen was burning until one of his circulating nurses smelled a ¿burning plastic¿ smell.¿ this report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Reported event of the plume pen melting the smoke evacuation tube is confirmed.Received one plp2020 in opened original packaging.Lot number was verified.Performed a visual inspection, the smoke tubing is melted at the distal end of the tubing.When opening the device, the wires were exposed that were connected to the circuit board.Performed a functional inspection using the esu system 7550 (c8406), the pencil functioned as intended.The pencil did heat up a small amount.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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of two reports, regarding two 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).Per the instructions for use, the user is advised the following: inspect instruments and cables for damage prior to each use, especially the insulation of laparoscopic/endoscopic instruments.This may be done visually under magnification or with a high voltage insulation testing device.Insulation failures may result in burns or other injuries to the patient or operator.This issue will continue to be monitored 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): MODERN MEDICAL EQUIPMENT; "unit a, 11/f.mai wah ind bld; 1-7 wah sing street; kwai chung, nt ; HK
• Manufacturer (Section G): MODERN MEDICAL EQUIPMENT; "unit a, 11/f.mai wah ind bld; 1-7 wah sing street; kwai chung, nt ; HK
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 13838622
• MDR Text Key: 287578249
• Report Number: 1320894-2022-00065
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10845854061282
• UDI-Public: (01)10845854061282(17)240729(10)210721
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/11/2022

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 Expiration Date: 07/29/2024
• Device Catalogue Number: PLP2020
• Device Lot Number: 210721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 03/21/2022
• Supplement Dates Manufacturer Received: 04/21/2022
• Supplement Dates FDA Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MEGADYNE ELECTRO SURGICAL UNIT.; MEGADYNE ELECTRO SURGICAL UNIT.; MEGADYNE GROUNDING PAD.; MEGADYNE GROUNDING PAD.
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic