MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENLIGHT XPS LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT

Model Number 0010-0210R

Device Problems Smoking (1585); Defective Device (2588); Device Displays Incorrect Message (2591)

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

Event Date 02/20/2024

Event Type  malfunction  

Event Description

It was reported that during a procedure, the console displayed error 211 and 213.The console was restarted, however, error 521 then displayed and a smell of smoke was reported.The biotech engineer attempted to restart the console to troubleshoot however, the console system did not work properly.The procedure was completed with the same device and no patient complications.

Manufacturer Narrative

The console was not returned for analysis; however, the console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, the complaint could be confirmed.The power board fuses were measured, and it was found that the fuse for laser power was blown.Unit needs new power distribution board, so a new power distribution board was fitted.Also, it was attempted to turn on unit and the fan ruined but no power with key turn.Suspect problem to be transformer or pca board.The reason for burning smell, could not be determined due to a lack of a returned product and insufficient information to determine the most probable cause for the reported issue.Based on review of all information available and analysis results, a conclusion code of cause not established was assigned to this investigation.

Event Description

It was reported that during a procedure, the console displayed error 211 and 213.The console was restarted, however, error 521 then displayed and a smell of smoke was reported.The biotech engineer attempted to restart the console to troubleshoot however, the console system did not work properly.The procedure was completed with the same device and no patient complications.

• Brand Name: GREENLIGHT XPS LASER SYSTEM
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS; 3070 orchard drive; san jose CA 95134 2011
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18862112
• MDR Text Key: 337554579
• Report Number: 2124215-2024-14201
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00878953001906
• UDI-Public: 00878953001906
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K092735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0010-0210R
• Device Catalogue Number: 0010-0210R
• Device Lot Number: XPS60543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2018
• 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