MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT ULTRACLEAN ELEC: 6" BLDE EXT IN; ULTRACLEAN ELECTRODES

Model Number	139110EXT
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used/damaged device was returned to conmed for evaluation.Visual inspection found damaged and breached insulation adjacent the distal end of the hub and proximal end of the shrink sleeve.The device showed charring and looked to be melted from heat or combustion, which left the metal electrode exposed.Potentially, there was a hole/tear/channel in the shrink sleeve insulation, or a gap between the hub and the shrink sleeve.It is likely that foreign material came in contact with the inner metallic electrode through one of these which led to the device failure.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 two-year review of complaint history revealed no prior similar complaints for this device family.In that same timeframe, (b)(4) units have been manufactured and shipped worldwide.The clinical data report, conmed active electrodes (b)(4), determines that this failure is acceptable when weighed against the benefits of use of the devices.The instructions for use advise the user of the following.-visually examine the devices for obvious physical damage including: cracked, broken or otherwise distorted plastic parts, cuts, punctures, nicks, abrasions, unusual lumps, significant discoloration.-verify that the electrode is full and securely seated in the handpiece before use.This incident type will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
A customer reported during a breast implant exchange, the (b)(4) tip was used with a valley lab energy generator on 30cut 60coag and the tip flashed.The surgeon immediately removed the device from the surgical site and visually inspected it for damage.He described the damage as "charred at the flash site".No patient or user injury was reported and this device malfunction did not cause a surgical delay.This report is raised on the basis of a reported device malfunction with potential for injury with recurrence.

• Brand Name: ULTRACLEAN ELEC: 6" BLDE 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: 7314392
• Report Number: 3007305485-2018-00045
• Device Sequence Number: 1847374
• Product Code: GEI
• UDI-Device Identifier: 40653405007341
• UDI-Public: (01)40653405007341(17)220718(10)201707194
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K991855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2018

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: Physician
• Device Expiration Date: 07/18/2022
• Device Model Number: 139110EXT
• Device Catalogue Number: 139110EXT
• Device Lot Number: 201707194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 63