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

Model Number	0642-395-01
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during preparation of the procedure, this fiber could not be used.The fiber was replaced, and the procedure was completed successfully using another fiber.There were no patient complications.Analysis of the returned fiber identified a connector fracture.
Additional Manufacturer Narrative
The fiber was returned and upon receipt at our quality assurance laboratory, this device was thoroughly analyzed.The fiber was received in one piece with no defects on the fiber body.The tip was degraded.During testing of the connector, no light was found to be exiting the connector face, which indicates the fiber experienced an internal connector fracture.The fiber was also functionally tested, and no aiming beam could be determined.The reported allegation was confirmed.Based on analysis results and information available, a fracture within the connector can occur during procedural handling of the fiber during setup or use.This connector fracture can result in an insufficient aiming beam or low laser energy output, up to a complete inability for the fiber to fire.According to the device instructions for use (ifu), the following is cautioned: 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.A device history record review indicates the device met all manufacturing specifications, and therefore the failure was unlikely related to manufacturing.

• Brand Name: SLIMLINE 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: 20789715
• Report Number: 2124215-2024-73723
• Device Sequence Number: 18116452
• Product Code: GEX
• UDI-Device Identifier: 17290109140183
• UDI-Public: 17290109140183
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 11/26/2024

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: 0642-395-01
• Device Catalogue Number: 0642-395-01
• Device Lot Number: 0009511222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2022
• 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: Male