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

Model Number	GA-2006098
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure to treat ureter stones, error 35 was received.After a while, they could not use the equipment anymore.The procedure was then cancelled.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 sedation.
Additional Manufacturer Narrative
D3.Manufacturer email: (b)(6).The console was not returned for analysis; however, this console was serviced at the customer's facility by a field service engineer (fse).All connections on the console were reset and the console was turned on.During investigation, error 35 occurred indicating a device issue with the control board.It is likely that the control board was damaged.Based on the information available, it is likely that the damage to the control board resulted in the reported event.
Event or Problem Description
It was reported that during the procedure to treat ureter stones, error 35 was received.After a while, they could not use the equipment anymore.The procedure was then cancelled.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 sedation.

• 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: 17337828
• Report Number: 2124215-2023-37089
• Device Sequence Number: 6477403
• Product Code: GEX
• UDI-Device Identifier: 07290109145990
• UDI-Public: 07290109145990
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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-2006098
• Device Catalogue Number: GA-2006098
• Device Lot Number: 0000000465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown