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

Model Number 0010-0210R

Device Problems Smoking (1585); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/22/2023

Event Type  malfunction  

Event Description

It was reported that the screen went black during use, and a burning smell was noticed.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

Manufacturer Narrative

The console was evaluated by a field service engineer (fse) at the customer's site.During functional evaluation of the console, the reported burning smell was confirmed.The fse replaced the cable assembly display power, voltage select board (vsb), power distribution board (pdb) and main control board (mcb), restoring console functionality.The console passed full functional and electrical safety testing.The damaged device and burning smell were most likely determined to be a defective cable.Based on the information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.

Event Description

It was reported that the screen went black during use, and a burning smell was noticed.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

Manufacturer Narrative

The console was evaluated by a field service engineer (fse) at the customer's site.The fse confirmed the black screen, and replaced the voltage select board (vsb), master control board (mcb), power distribution board (pdb), top cover and power cord, which resolved the issue.The laser console passed full functional and electrical safety testing.The vsb, mcb, pdb, top cover and power cord were returned for evaluation.During functional evaluation of the console, the reported burning smell was confirmed.Visual inspection did not identify any physical damage on the board.The top cover was visually tested and showed scratches and missing serial number identification tag.Functional test of the top cover showed that there was a failure to power up, and a black blank screen and burning smell were detected.It is likely that the failure to power up was due to an electrical fault in the vsb.

• 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: 18575238
• MDR Text Key: 333663559
• Report Number: 2124215-2024-03284
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00878953001906
• UDI-Public: 00878953001906
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• 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: XPS50502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1