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

Model Number	0644-008-01
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
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 connector had a distorted light exiting the face indicating an internal connector fracture.This complaint refers to eleventh fiber.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the fiber was thoroughly analyzed.Visual inspection confirmed that the fiber was received intact, with no external anomalies observed.Microscopic examination identified distorted light emission from the connector face, consistent with an internal connector fracture.Additionally, burn marks were observed on the connector, while the fiber tip exhibited normal degradation.Functional testing found the aim beam light was dim.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.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 (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.Hold the fiber tip to a non-reflective surface, and ensure that a circular red/green spot appears.If the spot is not circular, cleave the fiber.If the spot is weak or not visible, discard the fiber or return it to the supplier for replacement.With all the available information, boston scientific concludes that the reported fiber allegation was confirmed.Analysis with the microscope showed that distorted light was exiting the connector face, indicating an internal fracture of the connector, in addition to burn marks found on the connector.The observed condition of distorted light exiting the connector can be a result of an internal connector fracture.Fracture within the connector can occur during procedural handling of the fiber during setup, use or reprocessing.This connector fracture can result in an insufficient aiming beam or low laser energy output, up to a complete inability for the fiber to fire.The interaction of the console with the connector having this fracture likely led it to overheat causing the burn marks observed and blast shield damage.Boston scientific has assigned an investigation conclusion code of cause traced to component failure.Aware date was selected as date of event, as no event date was provided.

• 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): LUMENIS LTD; yokneam industrial park; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25437460
• Report Number: 2124215-2026-30589
• Device Sequence Number: 10359545
• Product Code: GEX
• UDI-Device Identifier: 07290109145594
• UDI-Public: (01)07290109145594(17)260228(10)73050321
• 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 Expiration Date: 02/28/2026
• Device Model Number: 0644-008-01
• Device Catalogue Number: 0644-008-01
• Device Lot Number: 0073050321
• 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: 08/06/2021
• 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