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

Model Number	0644-019-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a left distal ureterolithiasis procedure for kidney stone, when the fiber was removed from the patient, the fiber burst and broke, superficially burning the instrument technician finger.This fiber had 3 uses, a new fiber with zero uses was used to complete the procedure.There was no patient complication.
Event or Problem Description
It was reported that during a left distal ureterolithiasis procedure for kidney stone, when the fiber was removed from the patient, the fiber burst and broke, superficially burning the instrument technicians finger.This fiber had 3 uses, a new fiber with zero uses was used to complete the procedure.There was no patient complication.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis of the returned product found that the fiber was received in two pieces and the microscopic inspection of the fiber tip indicated it was degraded with burn marks on fiber jacket.Therefore, the complaint against fiber break was confirmed, the returned fiber had a body break.It is likely that procedural conditions of the device during set-up or use contributed to the fiber body break.A fiber could be damaged or kinked during setup and fully break once laser energy is applied.A device history record (dhr) review indicates the device met all manufacturing specifications, and therefore the failure was unlikely related to manufacturing.The labeling review found that the product ifu states, inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the fiber; return it to the supplier for replacement and a damaged fiber may cause accidental laser exposure or injury to the treatment room personnel or patient, and/or fire in the treatment room.Based on the information available and analysis result the investigation conclusion code assigned is cause traced to component failure which indicates: expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that during a left distal ureterolithiasis procedure for kidney stone, when the fiber was removed from the patient, the fiber burst and broke, superficially burning the instrument technician's finger.This fiber had 3 uses, a new fiber with zero uses was used to complete the procedure.There was no patient complication.

• 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): 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: 21843694
• Report Number: 2124215-2025-21840
• Device Sequence Number: 7963342
• Product Code: GEX
• UDI-Device Identifier: 07290109145587
• UDI-Public: (01)07290109145587(17)281026(10)15031123
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2025

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: 0644-019-01
• Device Catalogue Number: 0644-019-01
• Device Lot Number: 0015031123
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 05/19/2025; 07/31/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 06/10/2025; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• 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 Age: 70 YR
• Patient Sex: Unknown