MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RFB, CAMERA HEAD, NON-AC, HD560H ARTHROSCOPE

Catalog Number 72200561F

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Information (3190)

Event Date 07/03/2014

Event Type  malfunction  

Event Description

It was reported that the wires were burned.

• Brand Name: RFB, CAMERA HEAD, NON-AC, HD560H
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 7000 w william cannon dr.; austin, TX 78735
• MDR Report Key: 6984707
• MDR Text Key: 91086831
• Report Number: 1643264-2017-01164
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/27/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 72200561F
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/03/2014
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse