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)

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

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

The console was reviewed by a field service engineer in the health care facility.The top cover and cable assay display were replaced.After the repair, a functional test and calibration were performed and confirmed that the device was working according to specification.It is most likely that the damaged parts contributed to the reported clinical observations.

Event Description

It was reported that the display cable was burned.The issue has been noticed when the device was turned on.The display went black (black screen), and a burning smell was noticed.No patient involvement was reported.

Event Description

It was reported that the display cable was burned.The issue has been noticed when the device was turned on.The display went black (black screen), and a burning smell was noticed.No patient involvement was reported.

Manufacturer Narrative

The console was reviewed by a field service engineer in the health care facility.It was found that the display cable harness was burnt wires, therefore the allegation was confirmed.The top cover and cable assay display were replaced.After the repair, a functional test and calibration were performed and confirmed that the device was working according to specification.The display cable harness was returned to boston scientific, it was visually inspected, and it was found burnt with melted wires caused by an electrical short.The reported display screen issue and burning smell was most likely due to an electrical short in the display circuits.It drew high current causing the harness to melt.The evidence from the product investigation did not identify any potential product quality issue or any new patient harm.Therefore, it can be concluded that an electrical fault was the most probable cause of the complaint.

• 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): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18582135
• MDR Text Key: 334541493
• Report Number: 2124215-2024-03837
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

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: XPS50502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1