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

Model Number	0010-0070
Medical Device Problem Codes	Failure to Power Up (1476); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the unit was displaying error 832 code (test failed) occurred.The unit does not power on.There was no patient complication due to this event; however, the procedure was not completed.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
Event or Problem Description
It was reported that the unit was displaying error 832 code (test failed) occurred.The unit does not power on.There was no patient complication due to this event; however, the procedure was not completed.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
Investigation summary with all the available information, boston scientific concludes that the event is confirmed, as the field service engineer (fse) was able to replicate the reported 832 (test failed) error code during onsite evaluation.It is probable that the message displayed is related to the process control board (pcb) not performing within specifications, as the replacement of the pcb resolved the event.Device history record (dhr) the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.The device service history record review was completed.The review showed that the greenlight laser was installed on 30/07/2016.The system was last serviced on 09/07/2021.The greenlight laser was fully functional with no issues.Device technical analysis the product was not returned for analysis.However, the field service engineer (fse) evaluated the unit onsite.The fse found multiple 832 errors in the log file with the process control board (pcb) as source.Fse replaced the pcb and confirmed the unit works as intended.Labeling review a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the unit was displaying error 832 code (test failed) occurred.The unit does not power on.There was no patient complication due to this event; however, the procedure was not completed.The field service engineer (fse) replaced the rear panel board and diode power supply.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
Correction: section d4 lot number transfer to d4 serial number.Investigation summary with all the available information, boston scientific concludes that the event is confirmed, as the field service engineer (fse) was able to replicate the reported 832 (test failed) error code during onsite evaluation.It is probable that the message displayed is related to the process control board (pcb) not performing as intended, as the replacement of the pcb resolved the issue.Device history record (dhr) the device history record (dhr) confirmed that the greenlight laser console met all material, assembly and performance specifications.The device service history record review was completed.The review showed that the greenlight laser was installed on (b)(6) 2016.The greenlight laser was fully functional with no issues.Device technical analysis the greenlight laser console product was not returned for analysis and/or part was not returned.However, the field service engineer (fse) evaluated the unit onsite.The fse found multiple 832 errors in the log file with the process control board (pcb) as source.Fse replaced the pcb and confirmed the unit works as intended.Labeling review a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: GREENLIGHT HPS 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 ; 4089353452
• MDR Report Key: 12625669
• Report Number: 2124215-2021-30867
• Device Sequence Number: 3473860
• Product Code: GEX
• UDI-Device Identifier: 00878953000206
• UDI-Public: 00878953000206
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062719
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2021

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: 0010-0070
• Device Catalogue Number: 0010-0070
• Device Lot Number: HPS2632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 10/22/2021; 12/13/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 11/09/2021; 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown