MAUDE Adverse Event Report: MODERN MEDICAL EQUIP MFG LTD 20/CA PLUMEPEN ELITE (S); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	PLP1020
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.Device not yet received.
Event or Problem Description
The sales representative reported on behalf of the customer that the plp1020, 20/ca plumepen elite (s), was being used during an unknown procedure on an unknown date when it was reported, ¿the plume pen elite hand pieces must have an issue with the cut button as the staff say that they are activating the diathermy as soon as they are connected.¿.There was no initial report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed as planned.Further questioning was sent to the reporter to clarify if self-activation is being reported; however, we have not received an answer to date.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 plp1020, 20/ca plumepen elite (s), was being used during an unknown procedure on an unknown date when it was reported, ¿the plume pen elite hand pieces must have an issue with the cut button as the staff say that they are activating the diathermy as soon as they are connected.¿.There was no initial report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed as planned.Further questioning was sent to the reporter to clarify if self-activation is being reported; however, we have not received an answer to date.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device has not been returned to date and no photographic evidence was 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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 12 complaints, regarding 17 devices, for this device family and failure mode.During this same time frame 4,077,920 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 0.000004.Per the instructions for use, the user is advised to plug the 3-prong power cord into the electrosurgical generator of your choice, (figure 3).Confirm that all power settings on the generator are appropriate for the procedure being performed.The electrosurgical generator¿s intensity should be set as low as is necessary to achieve the desired effect.The plumepen elite is a monopolar electrode, the use of a dispersive electrode is required to prevent burns/injury to patient.Please refer to electrosurgical generator user manual and dispersive electrode instructions for use for additional instructions.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: 20/CA PLUMEPEN ELITE (S)
• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 17441350
• Report Number: 1320894-2023-00147
• Device Sequence Number: 19510613
• Product Code: GEI
• UDI-Device Identifier: 10845854061268
• UDI-Public: (01)10845854061268(17)251220(10)MM20221210
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/20/2025
• Device Catalogue Number: PLP1020
• Device Lot Number: MM20221210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic