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 Self-Activation or Keying (1557)

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

Event Date 10/24/2023

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 plpul2020, 20/ca ultra nonstick was tested pre-operatively on 24oct23 and the ¿plpul2020 connected to esu, not to neptune smoke evac and spontaneously activating - indicated by esu audible indication and light indicator.A new plpul2020 opened and connected to both esu and smoke evac port and worked correctly¿.The procedure was completed with an alternate same device with a slight delay.Further assessment revealed the device involved in the event was a plp2020 plumepen elite surgical smoke evac pencil, 10ft tubing,qty20 not the plpul2020.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

Received one plp2020 in opened original packaging.Lot number was verified.Performed a visual inspection internally, the coagulation button concaved and making continuous contact with the circuit board.Performed a functional inspection using the esu system 7550 (c8406), the device continuously activates without pressing the buttons.A likely cause of this issue is due to tissue or fluid ingress into the button site affecting button depression.A two-year lot history review shows this is the only event for this lot number and failure mode.A device history record (dhr) was requested and to date, a response was not received; therefore, a review cannot be conducted.A two-year review of complaint history revealed there has been a total of 48 reports, regarding 100 devices, for this device family and failure mode.During this same time frame 4,151,580 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 0.00002.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 plpul2020, 20/ca ultra nonstick was tested pre-operatively on (b)(6) 2023 and the ¿plpul2020 connected to esu, not to neptune smoke evac and spontaneously activating - indicated by esu audible indication and light indicator.A new plpul2020 opened and connected to both esu and smoke evac port and worked correctly¿.The procedure was completed with an alternate same device with a slight delay.Further assessment revealed the device involved in the event was a plp2020 plumepen elite surgical smoke evac pencil, 10ft tubing,qty20 not the plpul2020.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 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: 18169226
• MDR Text Key: 328938923
• Report Number: 1320894-2023-00253
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10845854061282
• UDI-Public: (01)10845854061282(17)251024(10)MM20221015
• 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: 12/27/2023

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: MM20221015
• 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: 11/20/2023
• Supplement Dates Manufacturer Received: 12/27/2023
• Supplement Dates FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic