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

Model Number	GA-0006000
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, there was an error message displayed and due to this, the procedure was cancelled.No patient outcome was reported.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, the console was serviced at the customer's facility by a field service engineer (fse).The cooling system was drained and the filter was cleaned.System set-up was the performed again, and all safety circuits passed without any errors.The console passed functional checks and power checks.It is probable that the filter could have affected the device performance leading to the event experienced by the customer.
Event or Problem Description
It was reported that during a procedure, there was an error message displayed and due to this, the procedure was cancelled.No patient outcome was reported.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.

• 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; hakidm; yokneam ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18623976
• Report Number: 2124215-2024-05351
• Device Sequence Number: 2506024
• Product Code: GEX
• UDI-Device Identifier: 07290109140544
• UDI-Public: 07290109140544
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2024

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-0006000
• Device Catalogue Number: GA-0006000
• Device Lot Number: 0000000787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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