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

Model Number	GA-0006902
Medical Device Problem Codes	Smoking (1585); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, a burning smell was noticed, and errors 188 and 58 displayed.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Event or Problem Description
It was reported that during the procedure, a burning smell was noticed, and errors 188 and 58 displayed.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
This console was serviced at the customer's site.The field service engineer (fse) found errors 188 and 58 and noticed that the ceramic fuse house and adapter were burnt and damaged.The reported event was confirmed.The fse replaced complete new ceramic fuse house and adapted water level.All the system tests were passed.The power output was also verified to be working as expected.After the field service engineer performed the replacement of the ceramic fuse and adapter, the issue was resolved, and the unit was within specification.As a result, the console was functioning as intended.The reported event found could have affected the device performance leading to the event experienced by the customer.

• Brand Name: MOSES PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD.; yokneam industrial park; hakidma st 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21191591
• Report Number: 2124215-2024-83833
• Device Sequence Number: 12958451
• Product Code: GEX
• UDI-Device Identifier: 07290109145150
• UDI-Public: 07290109145150
• 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
• Report Date (Section B): 02/20/2025

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-0006902
• Device Catalogue Number: GA-0006902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 02/20/2025
• Date Device Manufactured: 11/22/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown