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

Model Number	0644-016-01
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a ureteroscopy procedure, the fiber snapped and broke.Another fiber was used in order to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis identified the fiber was broken in two pieces, in addition, the fiber tip appeared broken too.It is likely that procedural handling and procedural conditions of the device during set-up and use contributed to the fiber body break and tip break.A partial body break or kink could have occurred during use and when it was inserted into the scope and fired it led to the fiber break.Instructions for use (ifu) state: inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the device; return it to the supplier for replacement.Hold the fiber tip to a non-reflective surface, and ensure that a circular red/green spot appears.If the spot is not circular, cleave the fiber.If the spot is weak or not visible, discard the fiber or return it to the supplier for replacement.Ensure the fiber is properly handled so that it is not damaged by being stepped on, pulled, left lying in a vulnerable position, kinked or tightly coiled.Improper use of the fiber or use of a damaged fiber may result in severe eye or tissue damage, or fire in the treatment room, or accidental laser exposure to the treatment room personnel or patient.
Event or Problem Description
It was reported that, during a ureteroscopy procedure, the fiber snapped and broke.Another fiber was used in order to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis identified the fiber was broken in two pieces, in addition, the fiber tip appeared broken too.It is likely that procedural handling and procedural conditions of the device during set-up and use contributed to the fiber body break and tip break.A partial body break or kink could have occurred during use and when it was inserted into the scope and fired it led to the fiber break.Instructions for use (ifu) state: inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the device; return it to the supplier for replacement.Hold the fiber tip to a non-reflective surface, and ensure that a circular red/green spot appears.If the spot is not circular, cleave the fiber.If the spot is weak or not visible, discard the fiber or return it to the supplier for replacement.Ensure the fiber is properly handled so that it is not damaged by being stepped on, pulled, left lying in a vulnerable position, kinked or tightly coiled.Improper use of the fiber or use of a damaged fiber may result in severe eye or tissue damage, or fire in the treatment room, or accidental laser exposure to the treatment room personnel or patient.
Event or Problem Description
It was reported that, during a ureteroscopy procedure, the fiber snapped and broke.Another fiber was used in order to complete the procedure.There were no patient complications reported.

• Brand Name: SLIMLINE SIS EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LIGHTGUIDEOPTICS INTERNATIONAL LTD; celtniecibas str 8; livani LV-53 16; LG LV-5316
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16512167
• Report Number: 2124215-2023-11028
• Device Sequence Number: 15048403
• Product Code: GEX
• UDI-Device Identifier: 17290109140190
• UDI-Public: 17290109140190
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 10/11/2023

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: 0644-016-01
• Device Catalogue Number: 0644-016-01
• Device Lot Number: 0006951122
• 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: 03/03/2023
• Supplement Date Received by Manufacturer: 06/28/2023; 09/21/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 07/18/2023; 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown