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

Model Number	0010-0210R
Medical Device Problem Codes	Defective Device (2588); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console yellow and blue pedals locked after being pressing.The pedal was very oxidize due to aging.A temporary repair was made to complete the procedure with this console with no clinical consequences to the patient.A new pedal was subsequently installed.
Additional Manufacturer Narrative
The console footswitch was not returned for analysis; however, this console was serviced at the customers facility by a field service engineer (fse).The fse replaced the console footswitch which led to aborting the procedure resolving the reported event.The review of the device history record (dhr) for this console confirmed that it met specification prior to release.A review of the service history record showed in the most recent console inspection that it was fully functional with no issues.Based on the information available, replacing the footswitch resolved the pedal lock function issue; therefore, the event is confirmed.
Event or Problem Description
It was reported that the yellow and blue pedals locked after pressing and were very oxidized due to aging.A temporary repair was made to complete the procedure with this console with no clinical consequences to the patient.A new pedal was subsequently installed.

• 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: 14626940
• Report Number: 2124215-2022-19993
• Device Sequence Number: 5013786
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2022

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: 05/17/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown