MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AURIGA XL; POWERED LASER SURGICAL INSTRUMENT

Model Number M0068FS4007G0

Device Problem Output below Specifications (3004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported that during the procedure, the laser light guide showed error messages 1301 and 1303 after 4 cycles.The console was in low-energy mode.The light guide was installed and tested in modes 300 and 500, however, the error messages still appeared.The procedure was not completed due to this event.There were no patient complications were reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.

• Brand Name: AURIGA XL
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18221485
• MDR Text Key: 329165084
• Report Number: 2124215-2023-66942
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068FS4007G0
• Device Catalogue Number: 4007
• Device Lot Number: 0100584623
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1