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	03/01/2025
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 used for 23/24 treatments.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.If the fiber tip is in contact with the tissue it may lead to damage of the tip.Due to the information provided, the conclusion code for this failure is unintended use error caused or contributed to event which states, the interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation.Blockb3: the exact date of the event is unknown.The provided event date, 03/01/2025, was chosen as the best estimate based on the date that the manufacturer became aware of the event, 03/07/2025.
Event or Problem Description
A fiber was returned with no allegation.Analysis of the return device identified that the fiber tip was broken.There was no further information reported.
Additional Manufacturer Narrative
Upon further review of the information available, boston scientific (bsc) had determinate that the device had return from switzerland, not from germany as it was initially report.Therefore, bsc had filled out report number 2124215-2025-36106 to the fda with the correct country of the event.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 used for 23/24 treatments.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.If the fiber tip is in contact with the tissue, it may lead to damage of the tip.Due to the information provided, the conclusion code for this failure is unintended use error caused or contributed to event which states, the interaction between the user and device, or sample, caused or contributed to the error.Based on analysis result, the interaction between the user and device caused or contributed to the reported event.B3: the exact date of the event is unknown.The provided event date, 03/01/2025, was chosen as the best estimate based on the date that the manufacturer became aware of the event, 03/07/2025.
Event or Problem Description
The device was return without event allegation.Upon the device was returned to the quality assurance lab, it was thoroughly analyzed, and it was found that the fiber tip was broken, this event is likely related with the usage of the device.

• 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 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21606393
• Report Number: 2124215-2025-15889
• Device Sequence Number: 18366711
• Product Code: GEX
• UDI-Device Identifier: 07290109141862
• UDI-Public: (01)07290109141862(17)281010(10)32809411
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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?: No
• Date Returned to Manufacturer: 10/07/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement 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
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown