MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VAS, HD, AC, 4MM X 30 DEG; NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Model Number	72202959
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device was foggy.The event occured during the procedure while surgeon was in the joint scoping and no back up device was available.No patient injury was reported.

• Brand Name: VAS, HD, AC, 4MM X 30 DEG
• Common Device Name: NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7550032
• Report Number: 3003604053-2018-00083
• Device Sequence Number: 16444302
• Product Code: EOB
• UDI-Device Identifier: 00885554018783
• UDI-Public: (01)00885554018783
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K043395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2018

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: 72202959
• Device Catalogue Number: 72202959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1