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

Model Number	0644-017-01
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
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 fiber was found damaged upon opening the package.There were no patient complications.Analysis of the returned device identified a connector fracture.
Additional Manufacturer Narrative
Upon receipt at the post-market quality assurance laboratory, the device was thoroughly evaluated.The reported event involved a fiber found damaged upon opening the package, and no patient complications occurred.The investigation confirmed distorted light exiting the connector face due to an internal connector fracture, which can lead to an insufficient or absent aiming beam and reduced or no laser energy output.Evidence also indicated that the fiber showed signs of prior use, suggesting the damage likely occurred during a previous handling cycle rather than due to manufacturing, as supported by dhr and prr reviews showing compliance with specifications and no anomalies.This type of failure is a known and documented risk device damaged prior to use and is mitigated through ifu instructions requiring inspection and verification of the fiber condition prior to use.The assigned investigation conclusion code is cause traced to component failure, indicating an expected or random component failure without any design or manufacturing issue.Therefore, no new safety concerns were identified, the clinical impact is minimal with no reported harm, and no escalation is required.

• 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: 25474193
• Report Number: 2124215-2026-31152
• Device Sequence Number: 10352280
• Product Code: GEX
• UDI-Device Identifier: 07290109145556
• UDI-Public: (01)07290109145556(17)300309(10)25111663
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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: 0025111663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• 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