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

Model Number	GA-2003476
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the console displayed error code 282 and the device cannot be used.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 aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Event or Problem Description
It was reported that during procedure the console displayed error code 282 and the device cannot be used.After that, additional information was receives indicating that this case was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
The console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, error 282 appears and stops.This is thought to be caused by a temporary communication error between the part that detects the laser and the board that controls the device.It was checked the continuity of communication cable and the connections of the connectors.It was also conducted a running test for about 30 minutes and confirmed that there were no errors.Therefore, the reported allegation was confirmed leading to the reported event.Error 282 indicates that the mmcu did not receive pyro data for a certain laser pulse.It leads to the system stopping lasing and giving a pop-up message to the user.The technical reason is that pyro data message was not received during lasing process handling in c28 via ipc communication channel.This message was overrun by chiller periodic monitoring message which was received at the same time.A synchronization problem causes an overrun and dropping of the pyro data message.To avoid task switching in the middle of pyro data message handling, a mutex will be added to the pyro data messages transmission, so that the message handling will not be interrupted till completion.This software change is not deemed to functionally impact the product performance and patient safety but is being made to improve user/service experience and brings the system back into specification.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.

• 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 st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18980905
• Report Number: 2124215-2024-18061
• Device Sequence Number: 5954963
• Product Code: GEX
• UDI-Device Identifier: 07290109145457
• UDI-Public: 07290109145457
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/06/2024

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-2003476
• Device Catalogue Number: GA-2003476
• Device Lot Number: 0000000086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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