MAUDE Adverse Event Report: ARTHREX ARTHREX SYNERGY LIGHT SOURCE; ARTHROSCOPE

Model Number UHD4 4K VISION LED

Device Problem Melted (1385)

Patient Problem No Information (3190)

Event Date 03/20/2017

Event Type  malfunction  

Event Description

Light source melted sterile drape.

• Brand Name: ARTHREX SYNERGY LIGHT SOURCE
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX
• MDR Report Key: 6442383
• MDR Text Key: 71233632
• Report Number: MW5068725
• Device Sequence Number: 1
• Product Code: HRX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UHD4 4K VISION LED
• Device Catalogue Number: 1911273
• Device Lot Number: 16042601R
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27 YR