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

Model Number	GA-2009996
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was evaluated by a boston scientific field service engineer (fse) at the facility.The fse identified that the breaker that the outlet was connected to was tripped.The breaker switch on the back of laser was tripped as well.The breaker switch was reset, and the unit turned on with no errors.The fse verified that the cooling system functioned properly, and the gauge read correct readings.The optics were inspected and verified, and the console was verified for near and far alignment.Power output tests were performed and verified to meet specifications.Based on this information, the reported event is confirmed.The fse solved the issue and t e console performs according to manufacturer specifications.Based on the analysis results, an evaluation conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during a laser lithotripsy procedure, the console prompted error 282.The customer turned the laser off, however the laser could not be turned back on then.After troubleshooting, the breaker switch on the laser was found to be on the off position and after, the laser was turned back on.The physician put a stent in the patient and brought the patient back again to complete the procedure as the stones were unable to be removed during the first attempt.The patient had been administered general anesthesia.The customer is requesting that a field service engineer(fse)come check out the console.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or when 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): BOSTON SCIENTIFIC CORPORATION; yokneam ind. park; hakidma 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19141226
• Report Number: 2124215-2024-23699
• Device Sequence Number: 7861557
• Product Code: GEX
• UDI-Device Identifier: 07290109145518
• UDI-Public: 07290109145518
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2024

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-2009996
• Device Catalogue Number: GA-2009996
• Device Lot Number: 0000001094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown