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

Model Number	72202961
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during case, when doing a demo of lens system at (b)(6) healthcare, the first telescope they use had a grainy picture and seemed to had water between the camera head and the scope.They change the scope during the second case and the quality of the picture was perfect.No patient injuries reported, no delays and back-up device was available.During the procedure there was loss of image, and a back-up was used to finish the procedure.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.
Additional Manufacturer Narrative
The initial incident report was submitted with incorrect manufacturing site registration number 1643264 (s+n oklahoma).The correct manufacturing site registration number is 3003604053(s+n andover).Corrected data: g1 contact information.

• Brand Name: VIDEOARTHROSCOPE, HD, 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: 8466706
• Report Number: 1643264-2019-00232
• Device Sequence Number: 1839470
• Product Code: EOB
• UDI-Device Identifier: 00885554024159
• UDI-Public: 00885554024159
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K043395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2020

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: 72202961
• Device Catalogue Number: 72202961
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 04/23/2019; 02/08/2020
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 04/24/2019; 02/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1