MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIDEOARTHORSCOPE HD 4MM X 70 DEG; NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Catalog Number	72202962S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during hip arthroscopy, the customer noticed the distal tip of the scope scratched.The procedure delayed more than 30 minutes and it is unknown if back-up was available.No patient injury or other complications were reported.
Additional Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint for the distal tip was damaged.A visual inspection was performed and showed the scope to have distal tip damage and a loose prism.This damage is caused by contact with another source.No manufacturing related defects were observed.
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.

• Brand Name: VIDEOARTHORSCOPE HD 4MM X 70 DEG
• Common Device Name: NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8388467
• Report Number: 3003604053-2019-00025
• Device Sequence Number: 1922560
• Product Code: EOB
• UDI-Device Identifier: 00885554024210
• UDI-Public: 00885554024210
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup,Followup
• Report Date (Section B): 07/03/2019

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 Catalogue Number: 72202962S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 04/10/2019; 07/02/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 04/11/2019; 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1