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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MODERN MEDICAL EQUIP MFG LTD PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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MODERN MEDICAL EQUIP MFG LTD PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number PLP2020
Device Problem Self-Activation or Keying (1557)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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 was being used during an unknown procedure on an unknown date when it was reported ¿smoke pencils started continuously firing when the cut button was pressed.When it was depressed, it did not stop firing.Once it happened when cutting had begun, the other time it started as soon as the pencil was plugged in.¿.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.
 
Manufacturer Narrative
The reported device has been returned to conmed; however, the evaluation of the device has not been completed.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
 
Manufacturer Narrative
Correction to e1 (b)(6).Received one plp2020 in original packaging.Lot number was verified.Performed a visual inspection, there were no obvious signs of abnormalities or defects.Performed a functional inspection using the system 5000 (c5731), the device functioned as intended and does not continuously self-activate.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).Per the instructions for use, the user is advised to plug the 3-prong power cord into the electrosurgical generator of your choice.Confirm that all power settings on the generator are appropriate for the procedure being performed.The electrosurgical generator¿s intensity should be set as low as is necessary to achieve the desired effect.Inspect instruments and cables for damage prior to each use, especially the insulation of laparoscopic/endoscopic instruments.We will continue to monitor for trends through the complaint system to assure patient safety.
 
Event Description
The sales representative reported on behalf of the customer, that the plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing was being used during an unknown procedure on an unknown date when it was reported ¿smoke pencils started continuously firing when the cut button was pressed.When it was depressed, it did not stop firing.Once it happened when cutting had begun, the other time it started as soon as the pencil was plugged in.¿.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.
 
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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 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 Key18190429
MDR Text Key328779278
Report Number1320894-2023-00256
Device Sequence Number1
Product Code GEI
UDI-Device Identifier10845854061282
UDI-Public(01)10845854061282(17)251223(10)MM20221216
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K103375
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPLP2020
Device Lot NumberMM20221216
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2023
Is the Reporter a Health Professional? No
Date Manufacturer Received12/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/24/2022
Is the Device Single Use? Yes
Patient Sequence Number1
Patient EthnicityNon Hispanic
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