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

Catalog Number 72202961S

Device Problem Optical Discoloration (2999)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2019

Event Type  malfunction  

Event Description

It was reported that during arthroscopy procedure, the lens was black.A backup device was available to complete the procedure, but it is unknown whether there was a delay.No patient injuries were reported.

Manufacturer Narrative

An evaluation was performed by the supplier and could confirm the customer complaint for the scope has no image.A visual inspection was performed and showed the scope to have a broken lens and dented outertube.This damage is caused by contact with another source.No manufacturing related defects were observed.

• Brand Name: VIDEOARTHROSCOPE HD 4MM X 30 DEG
• Type of Device: NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8438249
• MDR Text Key: 139431987
• Report Number: 3003604053-2019-00034
• Device Sequence Number: 0
• Product Code: EOB
• PMA/PMN Number: K043395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72202961S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1