MAUDE Adverse Event Report: MODERN MEDICAL EQUIP MFG LTD PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY20; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number PLP2520

Device Problem Self-Activation or Keying (1557)

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

Event Date 03/01/2024

Event Type  malfunction  

Event Description

The customer reported that the plp2520, plumepen elite surgical smoke evac pencil, 15ft tubing,qty20 was being used om (b)(6) 2024 during a lumbar laminectomy and "the bipolar electrocautery ws not working.They changed the bipolar cord and noticed that it still wasn't working.After further investigation it was recognized that the cautery was still activated.Bipolar will not work if cautery is activated.Cautery pencil was in the protective holster and not to be used at this time.Cautery pencil was removed from the filed.A new pencil was given.At that time the bipolar started working.¿.There was no impact or injury to the patient.The procedure was completed.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.

Event Description

The customer reported that the plp2520, plumepen elite surgical smoke evac pencil, 15ft tubing,qty20 was being used om 1mar24 during a lumbar laminectomy and "the bipolar electrocautery ws not working.They changed the bipolar cord and noticed that it still wasn't working.After further investigation it was recognized that the cautery was still activated.Bipolar will not work if cautery is activated.Cautery pencil was in the protective holster and not to be used at this time.Cautery pencil was removed from the filed.A new pencil was given.At that time the bipolar started working.¿.There was no impact or injury to the patient.The procedure was completed.This report is being raised due to the reported 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.A 2 year lot history review shows a total of 5 devices for this lot number and failure mode however, none are confirmed.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.(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, 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 18957929
• MDR Text Key: 338737644
• Report Number: 1320894-2024-00077
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10845854061305
• UDI-Public: (01)10845854061305(17)250626(10)MM20220688
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K230547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PLP2520
• Device Lot Number: MM20220688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic