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

Model Number	GA-0006902
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that errors 251: "case save mode", 254: "lasing parameters out of limit", 269: "lasing and safety-warm-up failed to get to the threshold" and 253: "lasing and safety-pyro low limit fail" displayed during two procedures.For one procedure, the console was restarted and the procedure could be completed without patient complications.For the second one, the procedure could not be completed.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Additional Manufacturer Narrative
The console was serviced onsite by a field service engineer (fse).The fse calibrated the console and suggested 3v instead of 4v.The device worked as expected.It is likely that the malfunction found could have affected the device performance leading to the event experienced by the customer.Based on available information, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that errors 251: "case save mode", 254: "lasing parameters out of limit", 269: "lasing and safety-warm-up failed to get to the threshold" and 253: "lasing and safety-pyro low limit fail" displayed during two procedures.For one procedure, the console was restarted and the procedure could be completed without patient complications.For the second one, the procedure could not be completed.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.

• Brand Name: MOSES PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma st 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: 19398935
• Report Number: 2124215-2024-29833
• Device Sequence Number: 20773941
• Product Code: GEX
• UDI-Device Identifier: 07290109145150
• UDI-Public: 07290109145150
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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-0006902
• Device Catalogue Number: GA-0006902
• 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: 04/28/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 05/26/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown