MAUDE Adverse Event Report: LUMENIS LTD LUMENIS SLIMLINE EZ SIS SINGLE USE LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	840-921
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a ureteroscopy procedure for the treatment of stones, the fiber broke.The procedure was completed with a second fiber.There were no patient complications.
Event or Problem Description
It was reported that during an ureteroscopy procedure for the treatment of stones, the fiber broke while inside the patient.The procedure was completed with a second fiber.There were no patient complications.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.However, visual inspection of the photo provided, confirmed a fiber body break.It is likely that procedural handling of the device, may have contributed to the fiber fracture.The fiber instructions for use mentions to do not pull aggressively on the fiber while it is connected to the laser and avoid clamping or clipping any devices such as a hemostat on to the fiber.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: LUMENIS SLIMLINE EZ SIS SINGLE USE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; hakidm st 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: 17762342
• Report Number: 2124215-2023-49246
• Device Sequence Number: 17915931
• Product Code: GEX
• UDI-Device Identifier: 17290109140206
• UDI-Public: 17290109140206
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K100228
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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: 840-921
• Device Catalogue Number: 840-921
• Device Lot Number: 0086240222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 09/17/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2022
• 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