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

Model Number	GA-0006900
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the console device displayed errors 253 and 273, the bleeding was stopped using an alternate device and the procedure was canceled.There was no reported permanent impairment or injury to the patient this event is being reported for a cancelled procedure with the patient under sedation or sedation status unknown.
Additional Manufacturer Narrative
The console and/or parts were not returned for analysis.However, a field service engineer (fse) performed an onsite field service to evaluate and carried out console repairs.During initial console evaluation, the console pyro board was found misaligned likely contributing to the reported difficulties.Although the customer did not report issues with the console high reflector (hr) and output coupler (oc) mirrors, the fse found them to be defective.The fse adjusted and aligned the pyro board and replaced the hr and oc components.After alignment of the console pyro board component by fse, no further error codes occurred.Alignment of the pyro board is part of the fse routine preventive maintenance.Although the customer did not report issues with the console high reflector (hr) and output coupler (oc) mirrors, the fse found them to be defective during evaluation.This finding is unrelated to the initial reported issue by the customer; however, the manufacturer is further investigating to determine root cause and if additional actions are required.
Event or Problem Description
It was reported, that during procedure, the console device displayed errors 253 (lasing and safety-pyro low limit fail) and 273 (safety ok h/w line fail).The bleeding was stopped using an alternate device and the procedure was canceled.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.

• Brand Name: MOSES PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6, yokneam; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; hakidman st. 6; hakidm 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16312326
• Report Number: 2124215-2023-04743
• Device Sequence Number: 12308320
• Product Code: GEX
• UDI-Device Identifier: 07290109145402
• UDI-Public: 07290109145402
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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-0006900
• Device Catalogue Number: GA-0006900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male