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	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Visual inspection found the fiber was received in one piece with no defects to the fiber body.Microscopic inspection found the fiber tip was degraded.In addition, the connector exhibited burn marks on the connector face, and no light was exiting the connector face, indicating an internal connector fracture.Functional testing confirmed the reported failure, as the aiming beam was barely visible.The fiber card was read successfully and confirmed one treatment used and nine treatments remaining.The observed internal connector fracture can occur during procedural handling of the fiber during setup, use, or reprocessing, and can result in an insufficient aiming beam, low laser energy output, or complete inability of the fiber to fire.The interaction between the console and the fractured connector likely led to overheating, causing the burn marks observed on the connector face.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.According to the device instructions for use (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.A review of the slimline sis hazard analysis was completed and confirmed that the event of fiber failure to operate 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 a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause traced to component failure.
Event or Problem Description
It was reported that during a procedure, the laser beam did not come out.The procedure was completed using another device without patient complications.Analysis of the returned fiber identified an internal connector fracture.

• 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: 25260072
• Report Number: 2124215-2026-27800
• Device Sequence Number: 5419434
• Product Code: GEX
• UDI-Device Identifier: 07290109145556
• UDI-Public: (01)07290109145556(17)290812(10)24102425
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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: 0024102425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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