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

Model Number	GA-0006900
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Output below Specifications (3004); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the laser device was making noise and had low output energy.The procedure was completed with this device.There were no patient complications were reported.
Additional Manufacturer Narrative
Correction to block d7a: sud reprocessed and reused.Correction to block g2: report source.The console was not returned for analysis; however, it was serviced at the facility of the customer by a field service engineer (fse).The laser was very loud, the protective optics (bladed shield) were defective, laser head number 2 and 3 had very poor pumping values.The protective optics was replaced; optics were taken.The coolant was replaced, and a performance test was carried out.The laser handed over ready for use.The laser heads 2 and 3 must be replaced promptly to ensure continued safe operation of the laser.The fse replacement of the bricks 2 and 3 has resolved the complaint.It is likely that the low coolant level was caused the abnormal sound reported.The malfunction found could have affected the device performance leading to the event experienced by the customer.A labeling review was performed.The instruction for use (ifu) includes specific warnings/instructions related to device low power and device noise, audible, such as when treating calculi (e.G.Urinary, biliary) migration of the stone may occur due to the mechanical effect of the laser energy (retropulsion).Migration may be avoided by several lasing techniques that are based on the laser interaction with the stone.Firstly, decreasing the laser energy and increasing the pulse frequency to maintain the required power output.Secondly, by using the moses mode that was shown to reduce retropulsion.A laser emission indication noted lasing displays on the control screen and an audible signal sound at all times during treatment to alert you that laser energy is being emitted.The audible signal is different for the right and left pedals.There is no indication that the device was not used in accordance with the ifu.The ifu has no issues with translation, wording, or graphics and therefore revision is not required.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 the laser device had noise and a low output energy.The procedure was completed with this device and no patient complications were reported.
Additional Manufacturer Narrative
Update to block b5: describe event or problem.The console was not returned for analysis; however, it was serviced at the customers facility by a field service engineer (fse).During the initial evaluation of the console, the laser was very loud, the protective optics (bladed shield) were defective, laser head number 2 and 3 had very poor pumping values.The fse replaced the protective optics and coolant, and recommended customers to have laser heads 2 and 3 components replaced promptly to ensure continued operation of the laser.The laser was handed over to the customer, ready to use.It is likely that the low coolant level or the defective shield was caused by the abnormal sound reported.The malfunction found could have affected the device performance leading to the event experienced by the customer.Boston scientific has not received from the facility any of the replaced components despite good faith efforts.A labeling review of the lumenis pulse 120h op manual.The instruction for use includes specific warnings/instructions related to device low power and device noise, audible, such as: laser emission indication: lasing displays on the control screen and an audible signal sound at all times during treatment to alert you that laser energy is being emitted.The audible signal is different for the right and left pedals.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications prior to initial installation.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 during a procedure the laser device was observed to be making a noise and had a low output of energy.The procedure was completed with the same console.There were no patient complications reported.

• 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; hakidm; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21361761
• Report Number: 2124215-2025-07714
• Device Sequence Number: 8518941
• Product Code: GEX
• UDI-Device Identifier: 07290109145402
• UDI-Public: (01)07290109145402(11)141109(10)39(21)39
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2025

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
• Device Lot Number: 0000000039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 04/04/2025; 08/06/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 04/28/2025; 08/28/2025
• Date Device Manufactured: 11/09/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown