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	02/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during procedure, the error codes 198, 189, 183 and 202 were observed.The procedure could not be completed due to this issue.There were no patient complications reported.
Event or Problem Description
It was reported that, during procedure, the error codes 198, 189, 183 and 202 were observed referring to a defective cooling unit.The procedure could not be completed due to this issue.The patient was under anesthesia at the time.There were no patient complications.Per additional information, there were two chillers replacements on the same device since the first replacement was also damaged.
Event or Problem Description
It was reported that, during procedure, the error codes 198, 189, 183 and 202 were observed referring to a defective cooling unit.The procedure could not be completed due to this issue.The patient was under anesthesia at the time.There were no patient complications.
Additional Manufacturer Narrative
The console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, the chiller had to be replaced twice since the second replacement was damaged.Therefore, the reported allegation was confirmed leading to the reported event.After replacing the second chiller, functional test was performed, and alignments were made.Most likely the component damaged could have affected the device performance.No further issues were identified during service, and the console was confirmed to be fully functional after replacing.A device history record review confirmed the device met all manufacturing specifications, a risk review confirmed that the event is accounted for in the risk documentation, and a labeling review confirmed the ifu includes appropriate warnings and instructions for use.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that, during procedure, the error codes 198, 189, 183 and 202 were observed referring to a defective cooling unit.The procedure could not be completed due to this issue.The patient was under anesthesia at the time.There were no patient complications.After that, the chiller had to be replaced twice since the second replacement was damaged.Additionally, functional test and alignments were performed.

• 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; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16405995
• Report Number: 2124215-2023-07676
• Device Sequence Number: 5632048
• 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,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/12/2023

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
• Device Lot Number: 0000000005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 03/06/2023; 03/10/2023; 05/18/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 03/07/2023; 03/13/2023; 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown