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 the fiber burnt and broke.There was no patient involvement.
Additional Manufacturer Narrative
With the available information, boston scientific concludes that the reported burn and fiber break events were confirmed through analysis of the media provided, as the image showed that the fiber body was broken.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.The ifu states: improper use of the fiber or use of a damaged fiber may result in severe eye or tissue damage; fire in the treatment room; or accidental laser exposure to the treatment room personnel or patient.It is likely that procedural conditions of the device during set-up or use contributed to the fiber body break.A fiber could be damaged or kinked during setup and fully break once laser energy is applied.
Event or Problem Description
It was reported that the fiber burnt 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; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD.; 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: 21981385
• Report Number: 2124215-2025-29235
• Device Sequence Number: 4478783
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: 04/16/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown