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

Model Number	GA-2006098
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a flexible lithotripsy procedure, when the system was turned on, the display appears reddish.The connectors on the display and cpu controller were reconnected, but the issue persisted, and the customer requested a display replacement.The patient was under general anesthesia, but there were no patient complications.The procedure was rescheduled due to the event.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia.
Event or Problem Description
It was reported that prior to a flexible lithotripsy procedure, when the system was turned on, the display appears reddish.The connectors on the display and cpu controller were reconnected, but the issue persisted, and the customer requested a display replacement.The patient was under general anesthesia, but there were no patient complications.The procedure was rescheduled due to the event.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
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 performed a troubleshooting attempt by disconnected and reconnected the connectors on the displayed, but the reported the issue persisted, therefore, the complaint was confirmed.The malfunction could affect the expected performance of the console and leading to the event described by the customer.The device history record confirmed that the device met with all manufacturing specifications prior to distribution and there were no manufacturing deviations.Based on analysis and the information available, 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): BOSTON SCIENTIFIC CORPORATION; yokneam ind. park; hakidma 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19144792
• Report Number: 2124215-2024-23785
• Device Sequence Number: 7335259
• Product Code: GEX
• UDI-Device Identifier: 07290109145990
• UDI-Public: 07290109145990
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown