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

Model Number	0644-018-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a trans ureteral lithotripsy procedure, the fiber broke and was damage on the internal distal side.Due to this, the procedure was completed using another device.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual examination of the fiber identified there were no damages or defects observed, the fiber received in one piece.The microscopic analysis confirmed the fiber tip is degraded and no defects on connector.The fiber was functionally tested.The testing conducted did not identify signs of breakage along the length of the fiber and there was no light exiting the connector face.Based on analysis results the fiber showed signs of normal usage and there was no fiber damages identified that could have caused or contributed to the reported.According to the device instructions for use (ifu), hold the fiber tip to a nonreflective surface and ensure that a circular red/green spot appears.If the spot is not circular, re-cleave the fiber (see postoperative instructions for details).If the spot is weak or not visible, discard the device or return to the supplier for replacement.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 trans ureteral lithotripsy procedure, the fiber broke and got damaged on the internal distal side.Due to this, the procedure was completed using another device.There were no patient complications.

• Brand Name: SLIMLINE SIS EZ
• 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: 20800366
• Report Number: 2124215-2024-74718
• Device Sequence Number: 6989960
• Product Code: GEX
• UDI-Device Identifier: 17290109147038
• UDI-Public: 17290109147038
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: 0644-018-01
• Device Catalogue Number: 0644-018-01
• Device Lot Number: 0092760522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2022
• 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