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	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that errors 58 (self test process failure (one of the tests completed with fail status)), 203 (charger error-charger fail (failed charging within timeout 300 ms)), and 208 (charger error-charger test fail) occurred prior to the procedure.Information regarding whether the patient had been sedated was not available.The procedure was then cancelled.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia or whose sedation status was unknown.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the customer's facility by a field service engineer (fse).The fse replaced the charger, adjusted the voltage, and tested the console.The console was then operating within specifications.Based on the information available, it is probable that the charger not working affected the device performance leading to the reported event.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the customer's facility by a field service engineer (fse).The fse replaced the charger, adjusted the voltage, and tested the console.The console was then operating within specifications.Based on the information available, it is probable that the charger not working affected the device performance leading to the reported event.
Event or Problem Description
It was reported that errors 58 (self test process failure (one of the tests completed with fail status)), 203 (charger error-charger fail (failed charging within timeout 300 ms)), and 208 (charger error-charger test fail) occurred prior to the procedure.Information regarding whether the patient had been sedated was not available.The procedure was then cancelled.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia or whose sedation status was unknown.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the customer's facility by a field service engineer (fse).The fse replaced the charger, adjusted the voltage, and tested the console.The console was then operating within specifications.The charger 3 phase assembly was later returned and received for analysis.Visual inspection found the board and electrical connections were in good condition.Based on the information available, it is probable that the charger not working affected the device performance leading to the reported event.
Event or Problem Description
It was reported that errors 58 (self test process failure (one of the tests completed with fail status)), 203 (charger error-charger fail (failed charging within timeout 300 ms)), and 208 (charger error-charger test fail) occurred prior to the procedure.Information regarding whether the patient had been sedated was not available.The procedure was then cancelled.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia or whose sedation status was 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): 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: 18461404
• Report Number: 2124215-2023-75397
• Device Sequence Number: 3100574
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/04/2024

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
• Device Lot Number: 0000000130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 01/17/2024; 06/24/2024
• Initial Report FDA Received Date: 01/07/2024
• Supplement Report FDA Received Date: 02/07/2024; 07/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown