MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIDEOARTHROSCOPE, HD, 4MM X 30 DEG

Catalog Number 72202961S

Device Problem Material Opacification (1426)

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

Event Date 03/07/2014

Event Type  malfunction  

Event Description

It was reported that the scope cannot be seen through.

• Brand Name: VIDEOARTHROSCOPE, HD, 4MM X 30 DEG
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: jim gonzales ; 7000 w william cannon dr.; austin, TX 78735
• MDR Report Key: 6956012
• MDR Text Key: 89932610
• Report Number: 3003604053-2017-00266
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K971253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72202961S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1