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

Model Number	AC-20055370
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a stapedectomy surgery, the fiber burnt out and broke in the middle creating fire.Laser was in default setting with power 10 w.The console seemed to be working fine.The physician immediately changed the laser.Later the procedure was completed using a non-fiber mode (free hand) with a micromanipulator.There were no patient complications.
Additional Manufacturer Narrative
Additional information received clarified that this report is a duplicate event and is reported under 2124215-2025-31269 and the analysis will be submitted after completion under mfr # 2124215-2025-29235.
Event or Problem Description
It was reported that, during a stapedectomy surgery, the fiber burnt out and broke in the middle creating fire.Laser was in default setting with power 10 w.The console seemed to be working fine.The physician immediately changed the laser.Later the procedure was completed using a non-fiber mode (free hand) with a micromanipulator.There were no patient complications.

• Brand Name: OTOLASE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; yokneam ind. 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: 22031891
• Report Number: 2124215-2025-31269
• Device Sequence Number: 13114672
• Product Code: GEX
• UDI-Device Identifier: 07290109141862
• UDI-Public: (01)07290109141862(17)280726(10)32287182
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K130164
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: AC-20055370
• Device Catalogue Number: AC-20055370
• Device Lot Number: 0032287182
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/09/2025
• Date Device Manufactured: 08/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown