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

Model Number	GA-2006098
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the distributor that, during the procedure to treat stones, when the console is started it turns off during auto-test and then starts again.This happens every time.The lvps and the charger were changed, but the issue has not resolved.The voltage output of the lvps is correct at 380 volts.The distributor is requesting advice on what to change or check on the console to resolve the issue.The patient had been sedated with general anesthesia prior to the procedure.The procedure was then cancelled.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported by the distributor that, during the procedure to treat stones, when the console is started it turns off during auto-test and then starts again.This happens every time.The lvps and the charger were changed, but the issue has not resolved.The voltage output of the lvps is correct at 380 volts.The distributor is requesting advice on what to change or check on the console to resolve the issue.The patient had been sedated with general anesthesia prior to the procedure.The procedure was then cancelled.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.
Additional Manufacturer Narrative
The console was not returned for analysis; however, media inspection of video provided by the customer shows the console turning off when the auto-test on the console starts.The console was serviced at the facility by the customer.The customer disconnected the fan that was connected to the cpu board, and then the console started normally without any problems.Another fan the customer had was connected to the console, and it started normally.Based on the information provided, it is likely that the fan was defective and could have resulted in the reported event.

• Brand Name: 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: 18905474
• Report Number: 2124215-2024-15551
• Device Sequence Number: 7876737
• Product Code: GEX
• UDI-Device Identifier: 07290109145990
• UDI-Public: 07290109145990
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024

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-2006098
• Device Catalogue Number: GA-2006098
• Device Lot Number: 0000000345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown