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

Model Number	GA-0000070
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the aiming beam does not align with the center when using acuspot.There was a possibility that the console's arm alignment was off.The issue was resolved by reconnecting the acupulse arm.It was communicated that there is no problem if the joystick rotates around once and does not break.No patient or procedure outcome information have been provided despite good faith efforts.
Additional Manufacturer Narrative
This report is being submitted to correct the report source (g2) in section g, all manufacturers.The referenced laser console was not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported console performance allegation cannot be confirmed.A service history was completed; the console was installed 11 years prior to the occurrence of this event.After this period, component wear, failure or damage is possible based on product used.A risk review was completed and confirmed that the event of misaligned articulated arm was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the information available, the most probably cause of the reported issue cannot be established due to lack of evidence.Therefore, a conclusion code of unable to exclude device problem was assigned to this investigation.
Event or Problem Description
It was reported that during procedure, the aiming beam does not align with the center when using acuspot.There was a possibility that the console's arm alignment was off.The issue was resolved by reconnecting the acupulse arm.It was communicated that there is no problem if the joystick rotates around once and does not break.No patient or procedure outcome information have been provided despite good faith efforts.

• Brand Name: ACUPULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24489605
• Report Number: 2124215-2026-10924
• Device Sequence Number: 5003650
• Product Code: GEX
• UDI-Device Identifier: 07290109140308
• UDI-Public: (01)07290109140308(11)140203
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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
• Device Lot Number: 0000001014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/08/2026
• Date Device Manufactured: 02/03/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACUSPOT.; ACUSPOT.
• Patient Sex: Unknown