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

Model Number	0644-021-01
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at the post-market quality assurance laboratory, the device was thoroughly evaluated.The reported event involved the absence of a visible aiming beam during the procedure, leading the user to switch to an alternate device without patient complications.The investigation confirmed distorted light exiting the connector face due to an internal connector fracture, along with burn marks and a weak aiming beam.This condition can impair targeting accuracy and potentially result in inadequate or misdirected energy delivery; however, the associated risk is low as the issue is detectable and mitigated through existing ifu instructions, which require inspection of the fiber and verification of beam quality prior to use.The failure mode is known, previously documented, and attributed to an expected random component failure rather than a design or manufacturing defect, as supported by dhr and prr reviews.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.
Event or Problem Description
It was reported that, during procedure, the aiming beam was not visible.The procedure was completed with another device.There were no patient complications.Analysis of the returned device identified a connector fracture.

• 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): MOLEX LLC; 18019 n 25th ave; phoenix AZ 85023
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25465466
• Report Number: 2124215-2026-31157
• Device Sequence Number: 21383635
• Product Code: GEX
• UDI-Device Identifier: 07290109145600
• UDI-Public: (01)07290109145600(17)290820(10)20410924
• 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): 06/10/2026

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
• Device Lot Number: 0020410924
• 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: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• 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 Age: 67 YR
• Patient Sex: Male