MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT ULTRACLEAN ELEC:1"NDLE;EXT IN; ULTRACLEAN ELECTRODES

Model Number	139105EXT
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported damaged device was not returned to conmed for evaluation, however, photographs of the device were taken, sent and inspected.The extended insulation of the electrode appeared black and charred.The insulation appears as if it combusted or was in proximity to material that combusted.A review of the manufacturing documents has verified the devices were produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture that would contribute to this issue.A historical review was completed and revealed 8 similar complaints for this device family in the past two years.In that same timeframe, (b)(4) units have been manufactured and shipped worldwide, making the rate of occurrence of this failure (b)(4).A clinical data report (cdr) states the undesirable side effects, under normal conditions of use, are acceptable when weighed against the benefits to the patients.The instructions for use advise the user to never use these devices in the presence of flammable gases, flammable prep solutions or drapes, oxidizing gases such as nitrous oxide (n2o) or in oxygen-enriched environments.This incident type will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
A customer reported to (b)(6), their distributor for item 139105ext ultraclean elextrode, that the bovie tip associated with mdr 3003705485-2018-00026 caused a flash fire during use.No patient injury was reported.These two 139105ext devices were returned unused to (b)(6) for testing, however, a photograph of the tip "charred" was provided.This report is raised on the basis of a photograph revealing a device malfunction.

• Brand Name: ULTRACLEAN ELEC:1"NDLE;EXT IN
• Common Device Name: ULTRACLEAN ELECTRODES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua, chihuahua 31136 ; MX 31136
• MDR Report Key: 7293882
• Report Number: 3007305485-2018-00027
• Device Sequence Number: 19089950
• Product Code: GEI
• UDI-Device Identifier: 40653405033258
• UDI-Public: (01)40653405033258(17)220815(10)201709164
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K991855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2018

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: 08/15/2022
• Device Model Number: 139105EXT
• Device Catalogue Number: 139105EXT
• Device Lot Number: 201708164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1