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

Model Number	GA-0000070
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001); Output below Specifications (3004); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the firing laser beam alignment was off, and the aiming beam is barely visible in low light.There was no patient involved.
Additional Manufacturer Narrative
The console was field service at the user's facility, it was found the coating of five mirrors in the console were weak and presented scratches.Upon inspecting the articulated arm, it was found that the mirrors were damaged.After replacing the mirrors and aligning the articulated arm, the issue was resolved, and the console was within specification and functioning as intended.Therefore, the reported complaint was confirmed.
Event or Problem Description
It was reported that the firing laser beam alignment was off, and the aiming beam is barely visible in low light.There was no patient involved.
Additional Manufacturer Narrative
The console was field service at the user's facility; it was found the coating of five mirrors in the console were weak and presented scratches.Upon inspecting the articulated arm, it was found that the mirrors were damaged.After replacing the mirrors and aligning the articulated arm, the issue was resolved, and the console was within specification and functioning as intended.In addition, four 25 mm arm mirrors and three 25 mm end joint arm mirrors were receipt at our post market quality assurance laboratory.Upon visual inspection it was noticed that the arm mirrors and end joints arm mirrors had surface damage.Therefore, the reported complaint was confirmed.
Event or Problem Description
It was reported that the firing laser beam alignment was off, and the aiming beam is barely visible in low light.There was no patient involved.

• 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: 19484473
• Report Number: 2124215-2024-34541
• Device Sequence Number: 7976902
• Product Code: GEX
• UDI-Device Identifier: 07290109140308
• UDI-Public: 07290109140308
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 11/24/2025

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: 0000000088
• 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: 05/16/2024
• Supplement Date Received by Manufacturer: 07/03/2024; 10/30/2025
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/30/2024; 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2012
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown