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

Model Number	GA-0000070
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the console displayed error 12 (co2 cooling flow switch error).There were no patient complications.Boston scientific has been unable to obtain additional information regarding the procedure outcome to date, despite good faith efforts.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.
Additional Manufacturer Narrative
The investigation confirmed the allegation that the console displayed error 12 (co2 cooling flow switch error) during the procedure, which resulted in the procedure being cancelled, though no patient complications were reported and additional details could not be obtained despite good faith efforts.Service evaluation showed the issue could not be reproduced; the cooling system was vented and refilled, system checks and safety tests were completed successfully, and the system was ultimately found to be fully operational.Labeling review confirmed that the ifu contains appropriate instructions for error messages and no evidence of misuse or labeling concerns was identified.A risk review determined that procedure delays or cancellations associated with this type of event are known, documented, and accounted for within the device risk management file.Because the available evidence does not allow confirmation or exclusion of a device related root cause, the investigation conclusion code assigned is unable to exclude device problem.The following fields were corrected: g2 report source.
Event or Problem Description
It was reported that during the procedure the console displayed error 12 (co2 cooling flow switch error) and it was not be able to keep been used during the procedure.Boston scientific has been unable to obtain additional information regarding the procedure outcome to date, despite good faith efforts.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; hakidm; yokneam ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23914201
• Report Number: 2124215-2025-93506
• Device Sequence Number: 9148661
• Product Code: GEX
• UDI-Device Identifier: 07290109140308
• UDI-Public: (01)07290109140308(11)140409
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: 0000001093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 03/23/2026
• Date Device Manufactured: 04/09/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown