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

Model Number	GA-0000070
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the screen displayed does not react.There were no patient complications, however, the event could not be completed due to this event.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.
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 physical inspection of the console and found that the displayed was defective therefore, replaced; thus, confirming the event reported.The displaye problem could have affected the device performance leading to the event experienced by the customer.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during a procedure, the screen displayed does not react.There were no patient complications, however, the event could not be completed due to this event.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.
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 physical inspection of the console and found that the displayed was defective therefore, replaced; thus, confirming the event reported.The display problem could have affected the device performance leading to the event experienced by the customer.The display was returned and visually inspected, and it was confirmed to be in good condition, including the electrical connector.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during a procedure, the screen displayed does not react.There were no patient complications, however, the event could not be completed due to this event.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.

• Brand Name: ACUPULSE
• 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 6; yokneam ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22786275
• Report Number: 2124215-2025-49663
• Device Sequence Number: 9906684
• Product Code: GEX
• UDI-Device Identifier: 07290109140308
• UDI-Public: (01)07290109140308(11)161222
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2026

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-0000070
• Device Catalogue Number: GA-0000070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 08/28/2025; 01/27/2026
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/17/2025; 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown