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

Model Number	GA-0008800
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the console displayed error codes 270 (system not operational for treatment.To operate the system, turn the key switch on, and restart system) and 58 (self-test process failure (one of the tests completed with fail status)).There were no patient complications, however the procedure could not be completed due to this event.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.
Event or Problem Description
It was reported that during preparation for a procedure, the console displayed error codes 270 (system not operational for treatment.To operate the system, turn the key switch on, and restart system) and 58 (self-test process failure (one of the tests completed with fail status).There were no patient complications, however the procedure could not start due to this event.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.
Additional Manufacturer Narrative
With all the available information, boston scientific concludes that the reported event was confirmed.As of today, the laser console has not been returned; therefore, no physical or visual analysis of the laser console could be performed.However, the console was serviced onsite by a field service engineer (fse).The fse performed a physical inspection of the console, and it was identified that the key switch was probably accidentally triggered, and that lead to the error code showed.The key switch was turned to the right position and that resolved the allegation reported.Based on review of all information available and analysis results, the investigation did not identify any abnormality in manufacturing or design from the risk review.The investigation is assigned a conclusion code of unintended use error caused or contributed to event.
Event or Problem Description
It was reported that during preparation for a procedure, the console displayed error codes 270 (system not operational for treatment.To operate the system, turn the key switch on, and restart system) and 58 (self-test process failure (one of the tests completed with fail status).There were no patient complications, however the procedure could not start due to this event.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.

• 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): BOSTON SCIENTIFIC CORPORATION; 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: 19125490
• Report Number: 2124215-2024-23110
• Device Sequence Number: 8283708
• Product Code: GEX
• UDI-Device Identifier: 07290109145419
• UDI-Public: 07290109145419
• 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,Foreign,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2024

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-0008800
• Device Catalogue Number: GA-0008800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 04/29/2024; 05/28/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 05/07/2024; 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown