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

Model Number	AC-10030100
Medical Device Problem Codes	Optical Problem (3001); Output Problem (3005); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During operation of moses laser staff noticed a "popping" and "cracking" sound.It was also noted the aiming beam was automatically turned off.The laser fiber was replaced, and the laser blast shield was changed.Laser fiber saved for materials management and blast shield given to plant ops.Patient was monitored.Supervisor notified.

• Brand Name: Moses¿
• Common Device Name: Powered Laser Surgical Instrument
• Manufacturer (Section D): LUMENIS LTD.; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 50927375
• Report Number: 50927375
• Device Sequence Number: 10739557
• Product Code: GEX
• UDI-Device Identifier: 07290109143170
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2026
• Report Date (Section F): 09/09/2026

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: AC-10030100
• Device Catalogue Number: AC-10030100
• Device Lot Number: 16932510
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/09/2026