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

Model Number	AC-20055370
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the power was not high enough to complete the procedure.It was found that the issue was with the fiber.Fiber tips were replaced but the issue continued.Different connections and setting were attempted but it did not work.There were no other fibers available, and the procedure was cancelled.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.
Event or Problem Description
It was reported that during procedure, the power was not high enough to complete the procedure.It was found that the issue was with the fiber.Fiber tips were replaced but the issue continued.Different connections and setting were attempted but it did not work.There were no other fibers available, and the procedure was cancelled.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.

• 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 st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20423283
• Report Number: 2124215-2024-62655
• Device Sequence Number: 7627156
• Product Code: GEX
• UDI-Device Identifier: 07290109141862
• UDI-Public: 07290109141862
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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 Model Number: AC-20055370
• Device Catalogue Number: AC-20055370
• Device Lot Number: 0032287187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 12/04/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown