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

Model Number	0010-0210R
Medical Device Problem Codes	Smoking (1585); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2124215-2024-03837
• Device Sequence Number: 7076962
• Product Code: GEX
• UDI-Device Identifier: 00878953001906
• UDI-Public: 00878953001906
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K092735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown