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

Model Number	0010-0210R
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when starting up the console, the screen displayed a goodbye message.Troubleshooting was attempted by rebooting the console; however, the message persisted.It was indicated that there was no patient involvement at the time of the event; however, the procedure was not completed due to this event.There were no clinical consequences to the patient.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Event or Problem Description
It was reported that when starting up the console, the screen displayed a goodbye message.Troubleshooting was attempted by rebooting the console; however, the message persisted.It was indicated that there was no patient involvement at the time of the event; however, the procedure was not completed due to this event.There were no clinical consequences to the patient.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the customer's facility by a field service engineer (fse).The fse confirmed that after powering up the console the "goodbye" message appeared and then the console powered off.The fse troubleshooted the system and noticed that all the fuses in the laser power supply and power distribution board were intact.After the resonator was checked, it was seen that the mode box was stuck in boot state.The fse updated the software to the resonator and that resolved the message.The fse then preemptively cleaned the fiber port and calibrated the console.The console passed all functional and electrical safety testing performed.The review completed on the dhr for this console confirmed that it met specification prior to release, and the most recent console inspection found it to be fully functional with no issues.Based on the information available, the cause that contributed to the reported courtesy error message event was most likely due to a software issue.

• 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 14550766
• Report Number: 2124215-2022-18951
• Device Sequence Number: 5158165
• 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): 07/05/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown