MAUDE Adverse Event Report: LUMENIS LTD MOSES PULSE; POWERED LASER SURGICAL INSTRUMENT

Model Number	GA-0006900
Medical Device Problem Codes	Degraded (1153); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console had a low performance or power.In addition, it was noted that error code 83 (brick 1 lamp has aged) was prompted.No further information was reported.Boston scientific has been unable to obtain additional information regarding procedure and/or patient outcome to date, despite good faith efforts.
Event or Problem Description
It was reported that the console had a low performance or power.In addition, it was noted that error code 83 (brick 1 lamp has aged) was prompted.No further information was reported.Boston scientific has been unable to obtain additional information regarding procedure and/or patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
The console was not returned for analysis; however, it was serviced at the customer's site by a field service engineer (fse).During inspection the fse checked the error logs and confirmed that errors 63 and 83 had occurred.Additionally, brick 1 had low output due to a burnt optic.The second relay mirror was found, replaced, and aligned.The coolant was topped up, and the debris shield was replaced.The reported low power issue was resolved after the debris shield was replaced.Additionally, the reported error 83 that occurred was resolved after the relay mirror was replaced.The console then passed functional testing and was ready for use.Since an expected or random component failure was identified without any design or manufacturing issue, the investigation conclusion code selected for this complaint is cause traced to component failure.

• Brand Name: MOSES PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23349745
• Report Number: 2124215-2025-74534
• Device Sequence Number: 15408554
• Product Code: GEX
• UDI-Device Identifier: 07290109145402
• UDI-Public: (01)07290109145402(11)140626(10)24
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170121
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: GA-0006900
• Device Catalogue Number: GA-0006900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/15/2025
• Date Device Manufactured: 06/26/2014
• 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