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	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer called the technical assessment center (tac) to report that the co2 laser was out of alignment.The customer was unsure whether the co2 misalignment was due to the micromanipulator, or the laser console.It was indicated that the console was not a boston scientific manufactured console.The tac recommended to utilize the console but without the micromanipulator.There was no patient involved.
Event or Problem Description
It was reported that the customer called the technical assessment center (tac) to report that the co2 laser was out of alignment.The customer was unsure whether the co2 misalignment was due to the micromanipulator, or the laser console.It was indicated that the console was not a boston scientific manufactured console.The tac recommended to utilize the console but without the micromanipulator.There was no patient involved.

• Brand Name: MICROSLAD
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; 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: 22689042
• Report Number: 2124215-2025-52671
• Device Sequence Number: 8255327
• Product Code: GEX
• UDI-Device Identifier: 07290109141817
• UDI-Public: (01)07290109141817(11)171110(10)368
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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: AA0886700
• Device Catalogue Number: AA0886700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/16/2025
• Date Device Manufactured: 11/10/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CO2 CONSOLE. (UNK MANUFACTURER); CO2 CONSOLE. (UNK MANUFACTURER)
• Patient Sex: Unknown