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	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2023
Type of Reportable Event	Malfunction
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 a spine case procedure on (b)(6) 2023 when it was reported, ¿once dr.(b)(6) was done with bovie, he placed it on the drape after use.The bovie tip burned the drape.Team changed the tip after this happened.¿.There was no report of injury, medical intervention, or hospitalization for the user or patient.The procedure was completed with an alternate device with no report of any delay time.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional 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.
Additional Manufacturer Narrative
The device will not be returned and no photographic evidence has been 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.(b)(4).Per the instructions for use, the user is advised the following: the electrode tip may remain hot enough to cause burns after current has been de-activated.The user is also advised that localized burns to the patient or physician may result from electrical currents carried through conductive objects.Current may be generated in conductive objects by direct contact with the active electrode, or by the active accessory being in close proximity to the conductive object.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 plp1020, 20/ca plumepen elite (s), was being used during a spine case procedure on (b)(6) 2023 when it was reported, ¿once dr.(b)(6) was done with bovie, he placed it on the drape after use.The bovie tip burned the drape.Team changed the tip after this happened.¿.There was no report of injury, medical intervention, or hospitalization for the user or patient.The procedure was completed with an alternate device with no report of any delay time.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• 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: 17299587
• Report Number: 1320894-2023-00128
• Device Sequence Number: 7036947
• Product Code: GEI
• UDI-Device Identifier: 20845854061265
• UDI-Public: (01)20845854061265(17)250627(10)MM20220675
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K103375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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: 06/27/2025
• Device Catalogue Number: PLP1020
• Device Lot Number: MM20220675
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic