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

Model Number	0644-019-01
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a sound was noticed during use, and the fiber was found to be burnt.The debris shield was also observed to be damaged.Due to this, the procedure could not be completed and was discontinued.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under general anesthesia.This complaint refers to the fiber.
Event or Problem Description
It was reported that a sound was noticed during use, and the fiber was found to be burnt.The debris shield was also observed to be damaged.Due to this, the procedure could not be completed and was discontinued.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under general anesthesia.This complaint refers to the fiber.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.The labeling review found that the product 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, and a damaged fiber may cause accidental laser exposure or injury to the treatment room personnel or patient, and/or fire in the treatment room.A risk review was completed and confirmed that the event of surgical procedure delayed and absence of treatment defined in the risk documentation and is documented.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A device history record (dhr) review indicates the device met all manufacturing specifications, and therefore the failure was unlikely related to manufacturing.Based on the information available, the cause that contributed to the reported event cannot be established.

• Brand Name: SLIMLINE SIS EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; 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: 24431346
• Report Number: 2124215-2026-10172
• Device Sequence Number: 21430705
• Product Code: GEX
• UDI-Device Identifier: 07290109145587
• UDI-Public: (01)07290109145587(17)300817(10)27630925
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 04/09/2026

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: 0644-019-01
• Device Catalogue Number: 0644-019-01
• Device Lot Number: 0027630925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/09/2026
• Date Device Manufactured: 09/17/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK-P-VPPS_SERIES LOT 27630925.; UNK-P-VPPS_SERIES LOT 27630925.
• Patient Sex: Unknown