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

Model Number	GA-0008700
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, error 273 (safety ok h/w line fail) and 253 (lasing and safety-pyro low limit fail) were displayed by the console.The device could not be used in the procedure and therefore the procedure was cancelled/rescheduled.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia or whose sedation status was unknown.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date, 11/01/2024, was chosen as the best estimate based on the date that the manufacturer became aware of the event, 11/27/2024.
Event or Problem Description
It was reported that during a procedure, error 273 (safety ok h/w line fail) and 253 (lasing and safety-pyro low limit fail) were displayed by the console.The device could not be used in the procedure and therefore the procedure was cancelled/rescheduled.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia or whose sedation status was unknown.
Additional Manufacturer Narrative
A work order was performed for this case, the field service engineer replaced the brick, the issue was resolved, and the unit was within specification.As a result, the console was functioning as intended.The malfunction found could have affected the device performance leading to the event experienced by the customer.Based on the information available, cause traced to component failure was assigned to conclusion code for this investigation.Blockb3: the exact date of the event is unknown.The provided event date, 11/01/2024, was chosen as the best estimate based on the date that the manufacturer became aware of the event, 11/27/2024.

• 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: 20947507
• Report Number: 2124215-2024-78174
• Device Sequence Number: 4592230
• Product Code: GEX
• UDI-Device Identifier: 07290109145464
• UDI-Public: 07290109145464
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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
• Device Lot Number: 0000000014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 02/06/2025
• Date Device Manufactured: 09/25/2017
• 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: Male