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

Model Number	0644-019-01
Medical Device Problem Codes	Nonstandard Device (1420); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, the device was thoroughly analyzed.The fiber was received in one piece and showed no external defects; however, the fiber body length was out of specification, indicating that a break had occurred.The other part was not returned.The instructions for use mentions the fiber length for slimline sis fibers is 310 (+-25 cm).The fiber successfully passed microscopic inspection and functional testing.Based on analysis results, it is likely that procedural conditions of the device during set-up or use contributed to the fiber body break.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The device instructions for use (ifu) advise the user to inspect the fiber for kinks, punctures, fractures, or other damage.According to the ifu, if the fiber appears damaged, do not use the fiber, return it to the supplier for replacement.
Event or Problem Description
It was reported that, during a holmium laser lithotripsy for bilateral ureteral calculi and in the process of breaking the stones, the fiber made an abnormal noise and stopped working immediately.Another fiber of the same lot number was used and had the same issue.The procedure was completed with a different fiber.There were no patient complications.Analysis of the returned device identified that the fiber was broken into two pieces.This complaint refers to the first fiber.

• 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 fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23611801
• Report Number: 2124215-2025-83043
• Device Sequence Number: 13212824
• Product Code: GEX
• UDI-Device Identifier: 07290109145587
• UDI-Public: (01)07290109145587(17)280722(10)12350723
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 11/20/2025

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: 0012350723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2023
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 64 KG