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

Model Number	GA-0008700
Medical Device Problem Codes	Smoking (1585); Defective Device (2588); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console was smoking and also presented with energy delivery failure, burnt spots, and a blow debris shield.Additionally, the fiber had visible sparks which is indicative of a fiber break.An orange and red ring was noted around the fiber followed by an unpleasant crackling noise before the fiber stopped working altogether.There was no further information provided on the procedure or patient outcome.This report is for the console.
Additional Manufacturer Narrative
This console was serviced at the customer's site.The field service engineer (fse) checked the system and noted debris shield had burnt spots.It is likely that the burned debris shield was causing the abnormal sound reported.The reported event was confirmed.Replacement of the debris shield was recommended to resolve the issue.The energy was verified using test fiber and was found within spec.After the fse performed the replacement of the ceramic fuse and adapter, the issue was resolved, and the unit was within specification.As a result, the console was functioning as intended.Therefore, the investigation was assigned the most probable conclusion code of cause traced to component failure.
Event or Problem Description
It was reported that console presented with energy delivery failure, a blown debris shield with burnt spots, and smoke.Additionally, a broken fiber with reported visible spark was observed.An orange/red ring was noted around fiber, and there was an unpleasant crackling noise, then stopped working altogether.No further information provided on procedure or patient outcome.This complaint is for the console.

• 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 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21701625
• Report Number: 2124215-2025-18823
• Device Sequence Number: 7867750
• Product Code: GEX
• UDI-Device Identifier: 07290109145464
• UDI-Public: (01)07290109145464(11)190812(10)32(21)32
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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-0008700
• Device Catalogue Number: GA-0008700
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/29/2025
• Date Device Manufactured: 08/12/2019
• 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