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

Model Number	GA-2006378
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the laser failed to power up during the startup sequence, the system was attempted to restart several times.The procedure was cancelled when the patient was under general anesthesia on the operation table.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
The device is not available for analysis; however, a field service work was performed.The system was inspected and found that the pt100 temperature was 80degrees.Temperature sensor replaced and system restarted, and temperature checked several times, fault does not re-occur.Full functionality testing carried out.No further faults found.After the temperature sensor replacement, the issue was resolved, and the unit was within the specification.The malfunction found could have affected the device performance leading to the event experienced by the customer.Based on the information available, the investigation conclusion code of cause traced to component failure was assigned for this complaint.
Event or Problem Description
It was reported that during a procedure, the laser failed to power up during the startup sequence, the system was attempted to restart several times.The procedure was cancelled when the patient was under general anesthesia on the operation table.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
The device is not available for analysis; however, a field service work was performed.The temperature sensor was returned, the visual inspection was showed that the component was in good physical condition, electrical connections were good.There was no functional test performed to determinate the functionality of the component.Temperature sensor was replaced and system restarted, and temperature checked several times, fault does not re-occur.Based on the information available, the investigation conclusion code of cause traced to component failure was assigned for this complaint.
Event or Problem Description
It was reported that during a procedure, the laser failed to power up during the startup sequence, the system was attempted to restart several times.The procedure was cancelled when the patient was under general anesthesia on the operation table.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.

• Brand Name: MOSES PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; israel 2069204; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD.; yokneam ind. park; hakidma 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20587386
• Report Number: 2124215-2024-65934
• Device Sequence Number: 12399683
• Product Code: GEX
• UDI-Device Identifier: 07290109144665
• UDI-Public: 07290109144665
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2025

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-2006378
• Device Catalogue Number: GA-2006378
• Device Lot Number: 0000001033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 11/17/2024; 01/08/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/06/2024; 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2024
• 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