MAUDE Adverse Event Report: OSTROLENK FABER GERB & SOFFEN AURIGA; POWERED LASER SURGICAL

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)

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

Event Date 06/13/2014

Event Type  malfunction  

Event Description

While using the 1000 micron laser fiber machine kept stalling.Surgeon would ask rn to check machine 3 times.Machine was turned on and off, and laser fiber was checked to make sure it was completely attached to laser machine.Laser was turned off.Called auriga to come and assess machine.

• Brand Name: AURIGA
• Type of Device: POWERED LASER SURGICAL
• Manufacturer (Section D): OSTROLENK FABER GERB & SOFFEN; 1180, avenue of the americas; new york NY 10036
• MDR Report Key: 3915383
• MDR Text Key: 4665006
• Report Number: 3915383
• Device Sequence Number: 1
• Product Code: GEX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2014
• Patient Sequence Number: 1