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

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  

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 without issue, with an alternate same device.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

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.

Manufacturer Narrative

Received two pl2020 opened original packages but only one device.Lot number was verified.Performed a visual inspection, no abnormalities or defects were confirmed.Performed a functional inspection using the esu system 7550 (c8406), the complaint wasn't confirmed.The device functioned as intended.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.

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 02nov23 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 without issue, with an alternate same device.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.

• 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 Key: 18216454
• MDR Text Key: 329123269
• Report Number: 1320894-2023-00257
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10845854061282
• UDI-Public: (01)10845854061282(17)251106(10)MM20221113
• 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: 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PLP2020
• Device Lot Number: MM20221113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 12/27/2023
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic