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

Catalog Number	72202961
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that upon switching on the camera system no clear picture could be seen on the screen, only a blurry, dull picture.After inspecting the lens the shaft appeared bent.This occurred at the start of a knee arthroscopy procedure.The surgery was postponed to another date as there was no back up available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, was used in a procedure, was not returned for evaluation.Visual inspection and functional testing could not be performed.A relationship, if any, between the device and the reported incident could not be confirmed.A dhr review was performed and showed no non conformances or deviations associated with the serial number provided.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 9337017
• Report Number: 3003604053-2019-00129
• Device Sequence Number: 1873358
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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: 72202961
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1