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

Model Number	AA0886700
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that aiming beam was not matched with working laser beam.There was no patient involved.
Additional Manufacturer Narrative
Correction to field a1: patient identifier.The console was field service at the user's facility.The console was inspected and it was found that the aiming beam and treatment beam matched the same path.However, the aiming beam had to be replaced.Tube alignment and aiming alignment was performed.Articulated arm alignment is not good so performed arm alignment.The console was tested and was functioning as intended.Based on investigation, the reported event was able to be confirmed.Service history was reviewed and it was identified that the device was installed on (b)(6) 2026 and this event occurred 7 years after the system installation.After this period, component wear, failure or damage is possible based on product use.A risk review was completed and confirmed that the event of micromanipulator misaligned 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.The defective aiming beam could have affected the device performance leading to the event experienced by the customer.Based on all information available and investigation results, an investigation conclusion code of cause traced to component failure was assigned to this investigation.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that that aiming beam was not matched with working laser beam.There was no patient involved.

• Brand Name: MICROSLAD
• 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: 24274640
• Report Number: 2124215-2026-06779
• Device Sequence Number: 21337528
• Product Code: GEX
• UDI-Device Identifier: 07290109141817
• UDI-Public: (01)07290109141817
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K151331
• 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): 04/15/2026

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: AA0886700
• Device Catalogue Number: AA0886700
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 04/15/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown