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

Model Number	GA-2006378
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fiber got stuck, after attempting multiple times the fiber was removed.Different fibers were tried, but none could be inserted in the console without feeling that force would have to be used, with the risk of the fiber getting stuck again.A new fiber focus assembly spare part will be sent.The procedure was abandoned.There were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the console component was thoroughly analyzed.Visual inspection of returned fiber focus assembly identified that it was in good physical condition, the electrical connections were in good condition, and the mirrors were clean.However, field service of the console at the user's facility identified that there was damage to the fiber port, and it was unable to connect fibers.Therefore, the reported allegation was confirmed.The fiber port assembly was replaced and aligned.After replacing and aligning the fiber port assembly, the issue was resolved.As result, the console was within manufacturer's specification and functioning as intended.
Event or Problem Description
It was reported that the during procedure the fiber got stuck, after attempting multiple times the fiber was removed.Different fibers were tried, but none could be inserted in the console without feeling that force would have to be used, with the risk of the fiber getting stuck again.A new fiber focus assembly spare part will be sent.The procedure was abandoned.There were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation.

• 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: 20728952
• Report Number: 2124215-2024-72483
• Device Sequence Number: 8304698
• 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
• Report Date (Section B): 02/17/2025

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: 0000000014
• 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: 10/29/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown