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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, 15FT TUBING,QTY20; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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MODERN MEDICAL EQUIP MFG LTD PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY20; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number PLP2520
Device Problem Self-Activation or Keying (1557)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2024
Event Type  malfunction  
Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.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 plp2520 plumepen elite surgical smoke evac pencil, 15ft tubing was being used during an unknown procedure on (b)(6) 2024 when it was reported ¿surgeon picked up cautery device and noted that the device was on prior to pushing button on device.Scrub tech noted that it seems that the cautery coag button was stuck.Device removed from field and placed in a red bag.¿.The procedure was completed and there was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
 
Event Description
The sales representative reported on behalf of the customer, that the plp2520 plumepen elite surgical smoke evac pencil, 15ft tubing was being used during an unknown procedure on (b)(6) 2024 when it was reported ¿surgeon picked up cautery device and noted that the device was on prior to pushing button on device.Scrub tech noted that it seems that the cautery coag button was stuck.Device removed from field and placed in a red bag.¿.The procedure was completed and there was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
 
Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.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 three (3) devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 134 complaints, regarding 541 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).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, 15FT 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 Key18969151
MDR Text Key338732513
Report Number1320894-2024-00079
Device Sequence Number1
Product Code GEI
UDI-Device Identifier10845854061305
UDI-Public(01)10845854061305(17)251103(10)MM20221106
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K230547
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPLP2520
Device Lot NumberMM20221106
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2022
Is the Device Single Use? Yes
Patient Sequence Number1
Patient EthnicityNon Hispanic
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