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

Model Number	0642-394-01
Medical Device Problem Codes	Overheating of Device (1437); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the indicator light gradually grew dimmer, indicating a decline in energy output.Over time, the crushing ability of the device diminished, and eventually, all energy ceased to flow.Upon inspecting the fiber connector, the core of the fiber was found burned.As a result, the procedure could not be successfully completed and patient was under general anesthesia.This event is being reported for aborted/cancelled procedure with a patient under sedation.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory this product underwent a thorough analysis.Visual analysis of the returned fiber identified that the tip had normal degradation.The fiber connector face exhibited some burn marks and melting.During functional testing, the aiming beam was very dim and distorted, but there was no light escaping from the fiber body.Based on analysis results, it is probable that the prolonged use of the fiber along with the damaged debris shield contributed to burn marks found on the connector and reported event.According to the instructions for use (ifu), the following is cautioned: the fiber face should be free of pits, scratches, discoloration, or debris.Using the device with such defects may destroy the device and damage the laser.
Event or Problem Description
It was reported that during procedure, the indicator light gradually grew dimmer, indicating a decline in energy output.Over time, the crushing ability of the device diminished, and eventually, all energy ceased to flow.Upon inspecting the fiber connector, the core of the fiber was found burned.As a result, the procedure could not be successfully completed and patient was under general anesthesia.

• Brand Name: SLIMLINE EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD.; hakidma st 6; yokneam AZ 20692 04; IS 2069204
• Manufacturer (Section G): MOLEX LLC; 18019 n 25th ave; phoenix AZ 85023
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17164386
• Report Number: 2124215-2023-31306
• Device Sequence Number: 12216950
• Product Code: GEX
• UDI-Device Identifier: 17290109140176
• UDI-Public: 17290109140176
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/15/2023

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 Expiration Date: 02/01/2024
• Device Model Number: 0642-394-01
• Device Catalogue Number: 0642-394-01
• Device Lot Number: 0031390319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Unknown
• Patient Weight: 60 KG