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

Model Number	AC-20055370
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Analysis of the returned fiber confirmed the reported event of fiber not firing, as analysis identified a fracture within the sub miniature a (sma) connector.Being that there is no aim beam exiting the tip; it is likely that there is a fracture within the sma connector.Fracture within the sma connector can occur during procedural handling of the fiber during setup, use, or reprocessing.The fiber connector may develop a microfracture that with use or handling can become larger resulting in an insufficient aiming beam and low laser energy output, up to a complete inability for the fiber to fire.The ifu states: fiber recognition: once connected, if the fiber icon and use indicator does not switch from grey to another color, the laser is not properly recognizing the fiber.It may be expired, inadequately connected to the system or defective.Fiber inspection: inspect the full length of the fiber for kinks, punctures, fractures, or other damage.Do not use if the fiber appears to be damaged.Check aiming beam: hold tip perpendicular and 1-4 mm away from a flat light-color surface.The aiming beam should have ideal or acceptable appearance.Do not use the fiber if the spot is unacceptable.A device history record (dhr) review was performed and confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during preparation of a procedure the fiber was fired twice, however, light was not emitted from the end of the fiber.The fiber was tried on two different laser consoles but was not tried on the patient.The fiber was replaced to complete the procedure.Analysis of the returned device identified a fiber connector fracture.

• 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 industrial park; hakidma; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19629643
• Report Number: 2124215-2024-39803
• Device Sequence Number: 7166032
• Product Code: GEX
• UDI-Device Identifier: 07290109141862
• UDI-Public: 07290109141862
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

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 Expiration Date: 04/27/2024
• Device Model Number: AC-20055370
• Device Catalogue Number: AC-20055370
• Device Lot Number: 0037330519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown