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 Problems Overheating of Device (1437); Insufficient Information (3190)

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

Event Date 11/09/2023

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 in use during a total hip procedure on (b)(6) 23 and the ¿lite pencil would not shut off and burned plastic holder¿.Further assessment confirmed that ¿the patient was not injured because they put the pencil back in the holder¿.The surgery was completed with an alternate like device.This reportedly occurred during pre-operative testing, and the reporter was not sure if any delay occurred.There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

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.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.A two-year lot history review cannot be conducted as a lot number was not provided.A device history record review (dhr) cannot be conducted as a lot number was not provided.(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 in use during a total hip procedure on (b)(6) 2023 and the ¿lite pencil would not shut off and burned plastic holder¿.Further assessment confirmed that ¿the patient was not injured because they put the pencil back in the holder¿.The surgery was completed with an alternate like device.This reportedly occurred during pre-operative testing, and the reporter was not sure if any delay occurred.There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.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, 10/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: 18286739
• MDR Text Key: 330467651
• Report Number: 1320894-2023-00263
• Device Sequence Number: 1
• Product Code: GEI
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic