MAUDE Adverse Event Report: LUMENIS LTD Moses Pulse; Powered Laser Surgical Instrument

Model Number	GA-0006802
Medical Device Problem Codes	Fire (1245); Failure to Power Up (1476); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after a component replacement, the unit would not power on consistently and continued to exhibit operational issues.During inspection, signs of burned material were observed inside the system.Although the unit was able to power on at times, the issue persisted.No patient involvement was reported.
Additional Manufacturer Narrative
An investigation confirmed failures related to the device powering up and evidence of thermal damage.Review of provided images revealed visible burn marks and discoloration on internal wiring and surrounding components, along with multiple system errors indicating impaired functionality.Despite prior component replacements, the issue was not resolved.The investigation determined that the observed operational issues were attributable to damage of an internal harness component.The event is consistent with an expected component-level failure.No manufacturing or design deficiencies were identified, and no further escalation is required.
Event or Problem Description
It was reported that after a component replacement, the unit would not power on consistently and continued to exhibit operational issues.During inspection, signs of burned material were observed inside the system.Although the unit was able to power on at times, the issue persisted.No patient involvement was reported.
Additional Manufacturer Narrative
Correction to field h11: additional mfr narrative.Correction to field h8: usage of device.An investigation confirmed failures related to the device powering up and evidence of thermal damage.Review of provided images revealed visible burn marks and discoloration on internal wiring and surrounding components, along with multiple system errors indicating impaired functionality.Despite prior component replacements, the issue was not resolved.The investigation determined that the observed operational issues were attributable to damage of an internal harness component.A risk review was completed and confirmed that the event of device fire was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The device history record review confirmed that the device met all material, assembly and performance specifications.The event is consistent with an expected component-level failure.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 after a component replacement, the unit would not power on consistently and continued to exhibit operational issues.During inspection, signs of burned material were observed inside the system.Although the unit was able to power on at times, the issue persisted.No patient involvement was reported.
Event or Problem Description
It was reported that after a component replacement, the unit would not power on consistently and continued to exhibit operational issues.During inspection, signs of burned material were observed inside the system.Although the unit was able to power on at times, the issue persisted.No patient involvement was reported.
Additional Manufacturer Narrative
This report is being filed for a correction to field (h6) device codes.An investigation confirmed failures related to the device powering up and evidence of thermal damage.Review of provided images revealed visible burn marks and discoloration on internal wiring and surrounding components, along with multiple system errors indicating impaired functionality.Despite prior component replacements, the issue was not resolved.The investigation determined that the observed operational issues were attributable to damage of an internal harness component.A risk review was completed and confirmed that the event of device fire was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The device history record review confirmed that the device met all material, assembly and performance specifications.The event is consistent with an expected component-level failure.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.

• 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): Boston Scientific Corporation; yokneam ind. park; hakidma 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24380538
• Report Number: 2124215-2026-09149
• Device Sequence Number: 18706710
• Product Code: GEX
• UDI-Device Identifier: 07290109145525
• UDI-Public: (01)07290109145525(11)240307(10)1530
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/14/2026

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-0006802
• Device Catalogue Number: GA-0006802
• Device Lot Number: 0000001530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 03/12/2026; 04/22/2026; 08/21/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/08/2026; 05/20/2026; 09/14/2026
• Date Device Manufactured: 03/07/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown