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

Model Number	0644-017-01
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Microscope inspection of the returned device showed that the fiber tip was broken, and the fiber jacket was shredded.No anomalies were identified at the connector.The observed damage is consistent with known and previously documented failure modes.The device instructions for use (ifu) was reviewed.The 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.It also states: ensure that the fiber tip is visible through the operating scope.Verify that the fiber tip was not damaged during the insertion of the fiber through the scope.The dhr review did not identify evidence of deviations or non-conformances in the manufacturing processes that could have contributed to the complaint.The device met all manufacturing specifications; therefore, the failure was unlikely related to manufacturing.A review of the slimline sis hazard analysis was completed and confirmed that the event of fiber tip break was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the information available, the failure was attributed to a confirmed component failure consistent with expected performance risks.Based on the available evidence, it is likely that procedural conditions, such as physician technique and the size and composition of the material being ablated, may have contributed to the damage observed.No indications of manufacturing or design issues were identified, and the failure mode was not new or unanticipated.Therefore, a conclusion code of cause traced to component failure was assigned, indicating an expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that the fibers have been damaging the debris shields, and abnormal degradation of the debris shields has been observed.No further information was provided.Analysis of the returned fiber identified that the fiber tip was broken.This report refers to fifth fiber.

• Brand Name: SLIMLINE SIS
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LIGHT GUIDE OPTICS INTERNATIONAL LT; celtniecibas str 8; livani LV-53 16; LG LV-5316
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25588147
• Report Number: 2124215-2026-33194
• Device Sequence Number: 20195016
• Product Code: GEX
• UDI-Device Identifier: 07290109145556
• UDI-Public: (01)07290109145556(17)291203(10)24107498
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/22/2026

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: 0644-017-01
• Device Catalogue Number: 0644-017-01
• Device Lot Number: 0024107498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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