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

Model Number	AC-0020170
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the micromanipulator needs alignment.The device is working; however the alignment seems to be off to the left when it is in use.There was no patient involved.
Additional Manufacturer Narrative
The console or components were not returned for analysis.However, the console was serviced onsite by a field service engineer (fse).During functional evaluation, the fse noticed that the problem was the lateral (x&y) position of the aiming beam coming from the micromanipulator relative to the microscope field of view (fov).When the joystick is centered on the manipulator and mounted to the zeiss microscope, the centered aiming beam is outside of the fov.This is caused from the mounting bracket not being the correct bracket for this manipulator attachment.The dovetail bracket on the manipulator fits loosely into the zeiss bracket.This variance causes the manipulator to sit incorrectly thus causing the out of alignment issue.After the fse adjusted the micromanipulator, the issue was resolved, and the unit was within specification.Based on available information, the investigation conclusion code selected for this complaint is cause traced to component failure.
Event or Problem Description
It was reported that the micromanipulator needs alignment.The device is working, however the alignment seems to be off to the left when it is in use.There was no patient involvement.

• Brand Name: ACUSPOT
• 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): BOSTON SCIENTIFIC CORPORATION; yokneam industrial park; hakidma st 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20142374
• Report Number: 2124215-2024-55115
• Device Sequence Number: 14240917
• Product Code: GEX
• UDI-Device Identifier: 07290109141954
• UDI-Public: 07290109141954
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K180597
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: AC-0020170
• Device Catalogue Number: AC-0020170
• Device Lot Number: 0000004085
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2023
• 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