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
Medical Device Problem Codes	Self-Activation or Keying (1557); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The sales representative reported on behalf of the customer that the plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing,qty (b)(4) was being used on 29apr24 during a total joint procedure and the ¿pencil is sticking and continues to fire." per further assessment it was found that the pencil kept activating and the surgery was completed normally using a different pencil.There was no report of impact or injury to the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer that the plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing,qty(b)(6) was being used on (b)(6) 2024 during a total joint procedure and the ¿pencil is sticking and continues to fire." per further assessment it was found that the pencil kept activating and the surgery was completed normally using a different pencil.There was no report of impact or injury to the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
One plp2020 received in opened original packaging.The returned lot was 20220950.Lot number was not verified.A visual inspection was performed, the electrode was returned with the device with melting on the insulator tip.Internally, the coag button is concaved making continuous connection with the circuit board.A functional inspection was performed using the esu system 7550 (c8406), the coag continuously activates when the device is plugged in.A root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be that a concaved coag button is causing internal wires to make contact leading to auto-activation.A two-year lot history review cannot be conducted as a lot number was not provided.A device history record (dhr) review cannot be conducted as a lot number was not provided.A two-year review of complaint history revealed there has been a total of 59 reports, regarding 91 devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised the following: inspect instruments and cables for damage prior to each use, especially the insulation of laparoscopic/endoscopic instruments.This may be done visually under magnification or with a high voltage insulation testing device.Insulation failures may result in burns or other injuries to the patient or operator.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing, qty (b)(4) was being used on (b)(6) 2024 during a total joint procedure and the ¿pencil is sticking and continues to fire." per further assessment it was found that the pencil kept activating and the surgery was completed normally using a different pencil.There was no report of impact or injury to the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction: lot history and dhr corrected from "a two-year lot history review cannot be conducted as a lot number was not provided.A device history record (dhr) review cannot be conducted as a lot number was not provided." to "a two-year lot history review for the lot number on the returned package shows a total of (b)(4) device for this returned lot number and failure mode.A device history record (dhr) review for the lot number on the returned package was requested from the manufacturer, and no indication of abnormalities was communicated.One plp2020 received in opened original packaging.The returned lot was 20220950.A visual inspection was performed, the electrode was returned with the device with melting on the insulator tip.Internally, the coag button is concaved making continuous connection with the circuit board.A functional inspection was performed using the esu system 7550 (b)(6), the coag continuously activates when the device is plugged in.A root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be that a concaved coag button is causing internal wires to make contact leading to auto-activation.A two-year review of complaint history revealed there has been a total of (b)(4) reports, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) 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 (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
• Common Device Name: 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: 19322533
• Report Number: 1320894-2024-00131
• Device Sequence Number: 6358193
• Product Code: GEI
• UDI-Device Identifier: 10845854061282
• UDI-Public: (01)10845854061282(17)250929(10)MM20220950
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K230547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/29/2025
• Device Catalogue Number: PLP2020
• Device Lot Number: MM20220950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 06/26/2024; 06/26/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/27/2024; 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic