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	02/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during preventive maintenance, the aiming beam was identified as to be not constant in the middle of the arm.It moves over the complete outcome.As a consequence, the laser occasionally strikes the end of the arm under specific conditions.There was no patient involved.
Event or Problem Description
It was reported that, during preventive maintenance, the aiming beam was identified as to be not constant in the middle of the arm.It moves over the complete outcome.As a consequence, the laser occasionally strikes the end of the arm under specific conditions.There was no patient involved.
Additional Manufacturer Narrative
The console was serviced at the customers site.The reported micromanipulator being misaligned allegation was confirmed.During service, the acuspot and the microscope were adjusted, therefore, it is likely that the acuspot mirror and microscope were defective requiring adjustment.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.A conclusion code of cause traced to component failure was assigned to this investigation.

• 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: 18846843
• Report Number: 2124215-2024-13518
• Device Sequence Number: 7814218
• Product Code: GEX
• UDI-Device Identifier: 07290109140308
• UDI-Public: 07290109140308
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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: GA-0000070
• Device Catalogue Number: GA-0000070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown