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

Model Number	0644-019-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure when the laser light was activated, it would run downwards.The event was described as a possible microfracture.It was confirmed that the fiber was physically broken.This was the fiber third used and it had been previously sterilized.The procedure was completed using a new fiber.There were no patient complications reported.
Additional Manufacturer Narrative
Correction to field h6: component codes.Correction to field h6: evaluation method codes.Correction to field h6: evaluation result codes.Correction to field h6: evaluation conclusion codes.
Event or Problem Description
It was reported that during procedure when the laser light was activated, it would run downwards.The event was described as a possible microfracture.It was confirmed that the fiber was physically broken.This was the fiber third used and it had been previously sterilized.The procedure was completed using a new fiber.There were no patient complications reported.
Event or Problem Description
It was reported that during procedure when the laser light was activated, it would run downwards.The event was described as a possible microfracture.It was confirmed that the fiber was physically broken.This was the fiber third used and it had been previously sterilized.The procedure was completed using a new fiber.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this fiber was thoroughly analyzed.Visual inspection did not find visible defects on the fiber body.Microscope inspection identified that the connector was in good condition.Also, during dimensional testing it was identified that the fiber was broken as it was not within the length specification for this device, microscope inspection identified that there were burn marks surrounding the break area.Therefore, the reported event was confirmed.

• 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: 19953870
• Report Number: 2124215-2024-49112
• Device Sequence Number: 8810394
• Product Code: GEX
• UDI-Device Identifier: 07290109145587
• UDI-Public: (01)07290109145587(17)280609(10)11960723
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 06/25/2025

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: 0011960723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 10/23/2024; 05/30/2025
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 11/15/2024; 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown