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
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.The fiber was received in one piece.During analysis with the microscope, a tip breakage was observed.Additionally, the connector looked in good condition.Functional testing passed however the aim beam light was distorted due to the tip breakage.A review of the slimline sis hazard analysis was completed and confirmed that the event of fiber device operates differently than expected 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.The device instructions for use was reviewed.According to the ifu, the following is cautioned: 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.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.With all the available information, boston scientific concludes that the reported fiber allegation was confirmed as the fiber tip was found broken.It is likely that procedural conditions, such as physician technique, size and composition of the material being ablated, may have contributed to the fiber tip break.The damaged fiber tip observed during inspection is consistent with the customer experience and suggests that mechanical stress from the fiber contributed to the abnormal wear of the debris shield.Boston scientific has assigned an investigation conclusion code of cause traced to component failure.
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 fourth 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: 25426922
• Report Number: 2124215-2026-30358
• Device Sequence Number: 9929474
• Product Code: GEX
• UDI-Device Identifier: 07290109145556
• UDI-Public: (01)07290109145556(17)291209(10)24107774
• 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): 06/08/2026

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: 0024107774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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