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	Burn(s) (1757)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure when the fiber was in use and lasering for thirty to forty minutes, the fiber snapped at approximately 90+ joules of use.The fiber was inspected and seemed fine per the customer, however, when the fiber had snapped it had wrapped around and snagged on the resectoscope and the camera drape, light lead, or the irrigation tubing as the snap in the fiber resulted in the consultant getting a small burn on their thumb.The wound was treated by washing and disinfecting the burn, applying a dressing, and then rescrubbing.The procedure was completed with another fiber there were no patient complications reported, and the status of the consultant remains unknown.
Event or Problem Description
It was reported that the fiber had been in use and lasering for thirty to forty minutes and approximately 90+ joules when the fiber snapped.The fiber was inspected and seemed fine per the customer.However, when the fiber had snapped it had wrapped around and snagged on the resectoscope and the camera drape, light lead, or irrigating tubing.The snap in the fiber resulted in the consultant getting a small burn on their thumb.The wound was treated by washing and disinfecting it, applying a dressing, and then rescrubbing to complete the procedure.The patient or procedure outcome information was not provided.

• 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: 50100164
• Report Number: 2124215-2026-41255
• Device Sequence Number: 18733970
• Product Code: GEX
• UDI-Device Identifier: 07290109145600
• UDI-Public: (01)07290109145600(17)280409(10)10900523
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 0010900523
• 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: 07/21/2026
• Supplement Date Received by Manufacturer: Not provided; 09/09/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 08/24/2026; 09/24/2026
• Date Device Manufactured: 05/11/2023
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown