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	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the operation, a foreign object that appeared to be a damaged tip of the fiber was found while making a final check of the surgical field, and it was lost before it could be removed.The procedure was completed with the same fiber.
Additional Manufacturer Narrative
Correction made to d3 manufacture name, manufacture address, manufacturer city, manufacturer zip/postal code, manufacturer country, manufacturer email, g1 mfr site facility name, mfr site address 1, mfr site city, mfr site state, mfr site zip, mfr site country, mfr site phone.
Event or Problem Description
It was reported that after the operation, a foreign object that appeared to be a damaged tip of the fiber was found while making a final check of the surgical field, and it was lost before it could be removed.The procedure was completed with the same fiber.
Additional Manufacturer Narrative
Correction made to d3 manufacture name, manufacture address, manufacturer city, manufacturer zip/postal code, manufacturer country, manufacturer email, g1 mfr site facility name, mfr site address 1, mfr site city, mfr site state, mfr site zip, mfr site country, mfr site phone upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis of the device did not identify any defects on the fiber.The fiber tip had loose material and charring, which are normal signs of use, and did not appear detached.Based on the information available and analysis results, 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 reported event of fiber break as analysis did not identify breaks along the fiber body.
Event or Problem Description
It was reported that after the operation, a foreign object that appeared to be a damaged tip of the fiber was found while making a final check of the surgical field, and it was lost before it could be removed.The procedure was completed with the same fiber.

• Brand Name: FIBERLASE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma st 6; yokneam AZ 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: 16782102
• Report Number: 2124215-2023-18432
• Device Sequence Number: 20432517
• Product Code: GEX
• UDI-Device Identifier: 07290109142012
• UDI-Public: 07290109142012
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2023

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 Model Number: AC-1059590
• Device Catalogue Number: AC-1059590
• Device Lot Number: 0001190822
• 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: 04/03/2023
• Supplement Date Received by Manufacturer: 09/22/2023; 10/06/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 09/22/2023; 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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