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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MODERN MEDICAL EQUIPMENT CO PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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MODERN MEDICAL EQUIPMENT CO 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 Date 11/02/2023
Event Type  malfunction  
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.We will continue to monitor for trends through the complaint system to assure patient safety.
 
Event Description
A sales representative reported on behalf of the customer that the device, plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing, was being used on (b)(6) 2023 wnen the ¿cautery pencil was somehow activating the cut without depressing the button during dr's case.The surgical tech, was able to hear it being activated and noticed that it no one was touching it.It was luckily in the holster and immediately removed.The surgical tech said that even after she removed the pencil from the holster, the cut was still activating despite nothing touching the switch.The foot pedal was not in use and nothing was depressing the pedals.No harm was done to the patient or staff¿.The procedure was completed with an alternate same device.Further assessment has been sought but a response has not been received.Two lot numbers have been provided in connection with this complaint; it is unknown which lot number refers to the device at issue.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
 
Event Description
A sales representative reported on behalf of the customer that the device, plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing, was being used on (b)(6) 2023 wnen the ¿cautery pencil was somehow activating the cut without depressing the button during dr's case.The surgical tech, was able to hear it being activated and noticed that it no one was touching it.It was luckily in the holster and immediately removed.The surgical tech said that even after she removed the pencil from the holster, the cut was still activating despite nothing touching the switch.The foot pedal was not in use and nothing was depressing the pedals.No harm was done to the patient or staff¿.The procedure was completed with an alternate same device.Further assessment has been sought but a response has not been received.Two lot numbers have been provided in connection with this complaint; it is unknown which lot number refers to the device at issue.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
 
Manufacturer Narrative
Device packaging was received but without the product; therefore, a device malfunction cannot be verified.If the device is returned at a later date, the investigation may be updated and reanalyzed.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 this is the only such occurrence for this lot number and failure mode.(b)(4).We will continue to monitor for trends 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 CO
unit a, 11/f.mai wah ind bldg
1-7 wah sing street
kwai chung, nt
HK 
Manufacturer (Section G)
MODERN MEDICAL EQUIPMENT CO
unit a, 11/f.mai wah ind bldg
1-7 wah sing street
kwai chung, nt
HK  
Manufacturer Contact
beth madeline
11311 concept blvd
largo, FL 33773
7274708358
MDR Report Key18216459
MDR Text Key329123333
Report Number1320894-2023-00258
Device Sequence Number1
Product Code GEI
UDI-Device Identifier10845854061282
UDI-Public(01)10845854061282(17)250823(10)MM20220841
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 Nurse
Type of Report Initial,Followup
Report Date 01/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPLP2020
Device Lot NumberMM20220841
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/24/2022
Is the Device Single Use? Yes
Patient Sequence Number1
Patient EthnicityNon Hispanic
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