MAUDE Adverse Event Report: LUMENIS LTD LUMENIS SLIMLINE SIS REUSABLE LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	840-923
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a ureteroscopy procedure, the fiber popped while using it and was not salvageable.The procedure was completed with another of the same device with no patient complications.
Event or Problem Description
It was reported that during a ureteroscopy procedure, the fiber popped while using it and wasnt salvageable.The procedure was completed with another of the same device with no patient complications.

• Brand Name: LUMENIS SLIMLINE SIS REUSABLE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; 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: 22472884
• Report Number: 2124215-2025-45649
• Device Sequence Number: 8113079
• Product Code: GEX
• UDI-Device Identifier: 07290109140223
• UDI-Public: (01)07290109140223(17)290125(10)16280224
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: 840-923
• Device Catalogue Number: 840-923
• Device Lot Number: 0016280224
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 09/09/2025
• Date Device Manufactured: 02/26/2024
• 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