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

Model Number	GA-0008700
Medical Device Problem Codes	Defective Device (2588); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a ureteroscopy procedure, the laser console made a strange noise, and the debris shield was found to be broken.The debris shield and the laser fiber were replaced, however, the noise still remained.The device was unable to be used and the procedure was rescheduled.The patient was sedated with general anesthesia.There were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
The console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, the focus lens has to be replaced.Therefore, the reported allegation was confirmed leading to the reported event.After replacing, the issue was resolved, and the unit was within specification.Most likely the malfunction found 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 ureteroscopy procedure the laser console made strange noise, the blast shield was broken.Therefore, this blast shield and the laser fiber were replaced but noise still remained.The device was unable to use, the procedure was not completed, it was re-scheduled.Patient was under general anesthesia, there was no patient complication.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is 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: 19456227
• Report Number: 2124215-2024-32267
• Device Sequence Number: 17805453
• 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): 07/25/2024

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
• Device Lot Number: 0000000014
• 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: 05/08/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 07/25/2024
• Date Device Manufactured: 09/25/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male