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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION GREENLIGHT XPS LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT Back to Search Results
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.
 
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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 Key18862112
MDR Text Key337554579
Report Number2124215-2024-14201
Device Sequence Number1
Product Code GEX
UDI-Device Identifier00878953001906
UDI-Public00878953001906
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K092735
Number of Events Reported1
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 Number0010-0210R
Device Catalogue Number0010-0210R
Device Lot NumberXPS60543
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/20/2024
Initial Date FDA Received03/07/2024
Supplement Dates Manufacturer Received04/04/2024
Supplement Dates FDA Received04/24/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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