MAUDE Adverse Event Report: SMITH & NEPHEW, INC PROCISE MINI LARYNGEAL COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EICA7071-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was making the machine flicker, lights flashing, making a loud noise.No patient injury reported.Delay greater than 30 minutes.
Additional Manufacturer Narrative
There was no relationship between the complaint and the returned device.Visual inspection under magnification shows minimal electrode wear.There is discoloration present on the exposed shaft and scuff marks present on the spacer.The saline line has been cut prior to being received for evaluation.There were no manufacturing abnormalities visually observed with the returned wand.The wand was connected to a compatible controller and activated in saline solution using default and max settings and performed as intended.The suction line was tested and performed as intended.Due to the saline line being severed, a syringe was used to push saline through-out the wand and there were no obstructions with the saline line.At no time during activation did the controller exhibit an image distortion.The complaint could not be verified as the returned device performed as intended.The root cause could not be determined with confidence as it is possible that other electrical equipment caused interference if the equipment was positioned near the system.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: PROCISE MINI LARYNGEAL COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7485432
• Report Number: 3006524618-2018-00221
• Device Sequence Number: 160409
• Product Code: GEI
• UDI-Device Identifier: 00817470004311
• UDI-Public: (01)00817470004311(17)201103(10)2007862
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K070374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2018

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 Model Number: EICA7071-01
• Device Catalogue Number: EDEICA7071-01
• Device Lot Number: 2007862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1