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

Model Number	AC-20055370
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is for the same event as manufacturer reports: 2124215-2024-27655, 2124215-2024-27659.
Event or Problem Description
It was reported that, during removal attempts of three fibers, they got stuck and subsequently broke inside the handpieces, damaging both the fibers and the handpieces and rendering them unusable.A thorough inspection of the laser equipment and alignment of the duo system shows no issues.There was no further information provided.This report is for fiber 1 of 3.
Additional Manufacturer Narrative
This report is for the same event as manufacturer reports: 2124215-2024-27655, 2124215-2024-27659.
Event or Problem Description
It was reported that, during removal attempts of three fibers, they got stuck and subsequently broke inside the handpieces, damaging both the fibers and the handpieces and rendering them unusable.A thorough inspection of the laser equipment and alignment of the duo system shows no issues.There was no further information provided.This report is for fiber 1 of 3.

• 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: 19272414
• Report Number: 2124215-2024-27652
• Device Sequence Number: 15311060
• Product Code: GEX
• UDI-Device Identifier: 07290109141862
• UDI-Public: 07290109141862
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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