MAUDE Adverse Event Report: Lumenis Ltd Lumenis Moses 200 D\F\L; powered laser surgical instrument

Model Number	1912-10
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction

• Brand Name: Lumenis Moses 200 D\F\L
• 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: 50926219
• Report Number: 2124215-2026-51585
• Device Sequence Number: 5804074
• Product Code: GEX
• UDI-Device Identifier: 07290109143170
• UDI-Public: (01)07290109143170(17)280219(10)14302507
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 1912-10
• Device Catalogue Number: 1912-10
• Device Lot Number: 0014302507
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown