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	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, with a patient on the table, two fibers from one lot and one more fiber from another lot failed to be recognized by the console.It was noted that the console issued error code 150 (laser deck - fiber not connected), which means the fiber wires were not connected to the console.The medical staff had already turned the laser off and on, checked the plugs, checked the "glass", but the laser continued to give error code 150 even with a new fiber of the same lot number.The procedure had to be stopped.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
Date of event: approximated.
Additional Manufacturer Narrative
Date of event: approximated as of today, the above referenced 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).It was identified that the fiber was too tightly attached to the console port, requiring it to be loosen up.The reported event was confirmed.After the fiber was loosen up and unscrewed, the fiber was reconnected again, and no error codes were issued.The issue was resolved.Based on analysis results, a conclusion code of unintended use error caused or contribute to event was assigned to this investigation.
Event or Problem Description
It was reported that, with a patient on the table, two fibers from one lot and one more fiber from another lot failed to be recognized by the console.It was noted that the console issued error code 150 (laser deck - fiber not connected), which means the fiber wires were not connected to the console.The medical staff had already turned the laser off and on, checked the plugs, checked the "glass", but the laser continued to give error code 150 even with a new fiber of the same lot number.The procedure had to be stopped.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

• 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 ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19166499
• Report Number: 2124215-2024-24436
• Device Sequence Number: 18129845
• Product Code: GEX
• UDI-Device Identifier: 07290109145464
• UDI-Public: 07290109145464
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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-0008700
• Device Catalogue Number: GA-0008700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown