MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT SYSTEM 2450 ESU; ELECTROSURGICAL GENERATOR

Catalog Number	60-2450-120
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint is not confirmed.Evaluation of the device found the front panel was damaged and missing a screw and the device required upgrade of the accessory contacts.Parts were replaced, the device repaired, the pm performed, and the device calibrated; the device passed testing the service history was reviewed, and no previous service data was found.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 were found to have met all specifications prior to shipment.(b)(4).Per the instructions for use, the user is advised the following: perform preliminary functional testing prior to each use to avoid unnecessary delays in surgery.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The conmed representative reported on behalf of the facility that the 60-2450-120, electrosurgical unit's middle port (2nd monopolar port) caused flames to come from the electrosurgical pencil.There was no reported user or patient injury or impact.Additional information received on june 11,2019 by the conmed sales representative stated the esu pencil was made by covidien.The tip of the pencil would create a flame when activated.This was found during pre-op testing and was found before any contact with the patient.The settings on the system 2450 were 30/30 cut/coag.The procedure was completed using another esu generator.The system 2450 was sent to the facility clinical engineering department and they could replicate the same result from the system 2450 and pencil.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: SYSTEM 2450 ESU
• Common Device Name: ELECTROSURGICAL GENERATOR
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; 31136 ; MX 31136
• MDR Report Key: 8697676
• Report Number: 3007305485-2019-00185
• Device Sequence Number: 1888928
• Product Code: GEI
• UDI-Device Identifier: 10653405061526
• UDI-Public: (01)10653405061526(11)180727
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K052009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2019

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 Catalogue Number: 60-2450-120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COVIDIEN ELECTROSURGICAL PENCIL