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

Model Number	GA-0006902
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the laser console prompt, case saver mode.The patient had already been sedated at the time of the console prompt.The procedure could not be completed due to this event and there was no serious injury to the patient.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
The console was not returned for analysis; however, an onsite inspection was conducted by a field service engineer (fse).Visual inspection of the console revealed error 253 and the optics misaligned thus confirming the reported allegation.The optics near and far alignment controlled, and the laser power were recalibrated.The instructions for use (ifu) mentions the case saver mode is a system state that enables the user to continue using the system safely; however, with reduce power capability.Based on fse service, the optics near and far alignment-controlled component, and laser power were recalibrated.After recalibrating the laser power and controlling the alignment for the optics the console was working as intended.It is likely that the optics were misaligned, resulting in the out of calibration of the power; therefore, contributing to the reported event which resulted in the event being aborted.
Event or Problem Description
It was reported that the laser console prompt, case saver mode.The patient had already been sedated at the time of the console prompt.The procedure could not be completed due to this event.There was no serious injury to the patient.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

• 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; hakidm st. 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17749216
• Report Number: 2124215-2023-50038
• Device Sequence Number: 17508164
• Product Code: GEX
• UDI-Device Identifier: 07290109145150
• UDI-Public: 07290109145150
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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-0006902
• Device Catalogue Number: GA-0006902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2022
• 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