MAUDE Adverse Event Report: Lumenis Ltd SlimLine SIS EZ; Powered Laser Surgical Instrument

Model Number	0644-021-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation prior to a procedure, it was noticed that the fiber was broken near the connector.The procedure was completed by using another fiber, patient outcome was not reported.
Event or Problem Description
It was reported that during preparation prior to a procedure, it was noticed that the fiber was broken near the connector.The procedure was completed by using another fiber, patient outcome was not reported.
Additional Manufacturer Narrative
The fiber was not returned to our post market quality assurance laboratory; therefore, neither a visual nor microscopic analysis was performed.The reported allegation of fiber break was not confirmed.A labeling review was performed.The labeling review found that the product ifu (instructions for use) 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 and 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.A risk review was completed and confirmed that the event of fiber break is defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A ship history review and a dhr (device history review) could not be performed due to the fiber upn and lot could not be identified.Based on the information available, a conclusion code of cause not established was assigned to this investigation.

• 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): LUMENIS LTD; hakidma st 6; yokneam, 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50526949
• Report Number: 2124215-2026-46110
• Device Sequence Number: 17655024
• Product Code: GEX
• UDI-Device Identifier: 07290109145600
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: 0644-021-01
• Device Catalogue Number: 0644-021-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 08/31/2026
• Supplement Report FDA Received Date: 09/21/2026
• 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