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

Model Number	AC-20055370
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis of the returned fiber showed no defects to the fiber body.During the microscope inspection, the fiber tip was observed broken; however, the connector was in good condition.The functional test showed that the fiber was use 23/24 treatments, and the aiming beam was bright and distorted due to tip break.It is likely that procedural handling and procedural conditions of the device during set-up or use contributed to the break.A review of the device history records confirmed that the fiber met specification prior to release.Based on thorough review of the analysis and information available, it is probable that unintended interaction between the user and device contributed to the break.The ifu states: the otolase delivery system is designed to be used in a non-contact mode.Avoid inadvertent contact between the otolase tip and tissue.Firing the laser when the otolase tip is in contact with the tissue will damage it.Firing the laser when the otolase tip is not in clear view may result in damage to non-target tissue and may cause inadvertent damage to the otolase tip or patient.
Event or Problem Description
The fiber was return to boston scientific without performance allegation description.Upon completion of the fiber analysis, it was identified that fiber tip was broken.Therefore, based on this specific analysis finding, reportability criteria is met.Boston scientific has been unable to obtain additional information despite good faith efforts.

• 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): LUMENIS LTD.; yokneam ind. park; hakidma 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22191455
• Report Number: 2124215-2025-36106
• Device Sequence Number: 8594297
• Product Code: GEX
• UDI-Device Identifier: 07290109141862
• UDI-Public: (01)07290109141862(17)281010(10)32809411
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2025

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: 0032809411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown