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U.S. Department of Health and Human Services

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

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MODERN MEDICAL EQUIPMENT PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
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.
 
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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 Key13838622
MDR Text Key287578249
Report Number1320894-2022-00065
Device Sequence Number1
Product Code GEI
UDI-Device Identifier10845854061282
UDI-Public(01)10845854061282(17)240729(10)210721
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103375
Number of Events Reported1
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 Date07/29/2024
Device Catalogue NumberPLP2020
Device Lot Number210721
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 03/03/2022
Initial Date FDA Received03/21/2022
Supplement Dates Manufacturer Received04/21/2022
Supplement Dates FDA Received05/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MEGADYNE ELECTRO SURGICAL UNIT.; MEGADYNE ELECTRO SURGICAL UNIT.; MEGADYNE GROUNDING PAD.; MEGADYNE GROUNDING PAD.
Patient Age84 YR
Patient SexFemale
Patient Weight99 KG
Patient EthnicityNon Hispanic
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