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

Catalog Number PLP2020

Device Problem Device Remains Activated (1525)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2023

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.H3 other text : device not yet received.

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 (b)(6) 2023 date when it was reported ¿cautery continues to work even when they remove their finger from the coag button.¿.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 device has not been returned to date and no photographic evidence has been provided; therefore, the reported event 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 2 for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 50 complaints, regarding 74 devices, for this device family and failure mode.During this same time frame (b)(4) 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.

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 (b)(6) 2023 date when it was reported ¿cautery continues to work even when they remove their finger from the coag button.¿.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.

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 (b)(6) 2023 date when it was reported ¿cautery continues to work even when they remove their finger from the coag button.¿.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

Follow up evaluation: received one plp2020 in opened 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 esu system 7550 (c8406), the device functioned as intended and did not continuously activate.Previous evaluation: the device has not been returned to date and no photographic evidence has been provided; therefore, the reported event 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 2 devices for this lot number and failure mode.(b)(4).We will continue to monitor for trends through the complaint system to assure patient safety.

• 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 Key: 17896944
• MDR Text Key: 325846302
• Report Number: 1320894-2023-00203
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10845854061282
• UDI-Public: (01)10845854061282(17)251223(10)MM20221217
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K103375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2024

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: MM20221217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 11/20/2023; 01/08/2024
• Supplement Dates FDA Received: 11/21/2023; 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic