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

Model Number	GA-2003322
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that console was unable to be used as the ready button could not be pressed even if the fiber is connected.The console was rebooted but still did not work, leading to the cancellation of the procedure.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that console was unable to be used as the ready button could not be pressed even if the fiber is connected.The console was rebooted but still did not work, leading to the cancellation of the procedure.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Additional Manufacturer Narrative
D3.Manufacturer email (b)(6).As of today, the above referenced laser console has not been returned; therefore, no physical or visual analysis of the laser console could be performed.However, the console was serviced onsite by a field service engineer (fse).The fse replaced a faulty charger which resolved the issue.Based on the analysis results, the reported ready button unable to be pressed was confirmed as replacing the faulty charger resolved the issue.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.

• 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.; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17240205
• Report Number: 2124215-2023-33846
• Device Sequence Number: 6831528
• Product Code: GEX
• UDI-Device Identifier: 07290109145983
• UDI-Public: 07290109145983
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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-2003322
• Device Catalogue Number: GA-2003322
• Device Lot Number: 0000000093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown