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

Model Number	GA-0000070
Medical Device Problem Codes	Fire (1245); Nonstandard Device (1420); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The console was field service at the user's facility.Upon started normally during power on self-test.However, the console's error logs showed error 55 (co2 on line limits sw compare error).The energy was check and it was found to be insufficient, also the aiming beam was weak.The console fire normally, but the energy is below standard.The power tube and aiming beam need to be replaced.Device was installed on 2/18/2016 and this event occurred over 9 years after the system installation.After this period, component wear, failure or damage is possible based on product use.A risk review of the acupulse hazard analysis was completed and confirmed that the event of device fire 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 all available information, replacement of the power tube and aiming beam were recommended to resolve the issue.The malfunction found could have affected the device performance leading to the event experienced by the customer.Therefore, the reported event of device fire was confirmed.Thus, an investigation conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during preparation for procedure, it was noticed that the device was severely carbonized and had insufficient power, the aiming light was also diverging.The procedure was completed using another console.There were no patient complications.
Event or Problem Description
It was reported that during preparation for procedure, it was noticed that the device was severely carbonized and had insufficient power, the aiming light was also diverging.There was a patient involved at the time of event, however, there is no information related to patient nor procedure outcome.

• 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 st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24420916
• Report Number: 2124215-2026-09915
• Device Sequence Number: 5879906
• Product Code: GEX
• UDI-Device Identifier: 07290109140308
• UDI-Public: (01)07290109140308(11)151125
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 03/27/2026

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: 0000001439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 11/25/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown