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

Model Number	AC-1059590
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: exact event date is unknown.
Event or Problem Description
It was reported that during a procedure, the laser fibers broke.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
Date of event: exact event date is unknown.Report source: correction.Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis did not reveal any anomaly with the returned fiber.The packaging was intact.The fiber was returned within an unopened box.The fiber was inside the pouch and analysis did not identify any fiber break.The reported allegation cannot be confirmed.Based on the information available, a conclusion code of no problem detected was assigned to this investigation.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.
Event or Problem Description
It was reported that during a procedure, the laser fibers broke.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

• Brand Name: FIBERLASE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma 6,; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): MOLEX LLC; 18019 n 25th ave; phoenix AZ 85023
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18754070
• Report Number: 2124215-2024-09789
• Device Sequence Number: 12346716
• Product Code: GEX
• UDI-Device Identifier: 07290109142012
• UDI-Public: 07290109142012
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K151331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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-1059590
• Device Catalogue Number: AC-1059590
• Device Lot Number: 0012200723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2023
• 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