MAUDE Adverse Event Report: LUMENIS LTD MICRO-G OTOLOGY KIT; POWERED LASER SURGICAL INSTRUMENT

Model Number	AC-1148100
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a stapes procedure, the aiming beam could not be seen though the device.The procedure needed to be rescheduled.There was no reported permanent impairment or injury to the patient.This event is being reported for an aborted procedure with patient under general anesthesia or sedation status unknown.
Event or Problem Description
It was reported that during a stapes procedure, the aiming beam could not be seen though the device.The procedure needed to be rescheduled.There was no reported permanent impairment or injury to the patient.The console was tested according to the ifu prior to the sedation.
Additional Manufacturer Narrative
Upon receipt of this microlase otology kit at our quality assurance laboratory, this device was thoroughly analyzed.Visual inspection was performed on returned device.No obvious damage, scratches or charring was observed.Slight bends associated with use were noted on the distal end of device.During functional testing, the laser light was used and able to pass through the tip area; therefore, the reported event cannot be confirmed.

• Brand Name: MICRO-G OTOLOGY KIT
• 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; hakidm; yokneam ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16616886
• Report Number: 2124215-2023-14108
• Device Sequence Number: 17712395
• Product Code: GEX
• UDI-Device Identifier: 07290109142074
• UDI-Public: 07290109142074
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2023

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: 09/06/2023
• Device Model Number: AC-1148100
• Device Catalogue Number: AC-1148100
• Device Lot Number: 0093230522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 03/26/2023
• Supplement Report FDA Received Date: 11/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown