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

Model Number	0642-393-01
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fiber was connected to the holmium laser but there was no energy emission.The fiber was replaced to complete the procedure without patient complications.After that, the product was returned for analysis, and it concluded that there was an internal connector fracture.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Analysis of the returned product identified that the fiber was received in one piece.Visual inspection of the fiber body did not exhibit any breaks.Additionally, it was found that there was no light exiting the fiber connector, indicating a fracture in the connector.Fracture within the connector can occur during procedural handling of the fiber during setup or use.The connector fracture can result in an insufficient aiming beam or low laser energy output, up to a complete inability for the fiber to fire.A review of the device instructions for use (ifu) was completed, the ifu states: hold the fiber tip to a nonreflective surface and ensure that a circular red/green spot appears.If the spot is not circular, re-cleave the fiber.If the spot is weak or not visible, discard the device or return it to the supplier for replacement.Based on analysis and the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Analysis of the returned product identified that the fiber was received in one piece.Visual inspection of the fiber body did not exhibit any breaks.Additionally, it was found that there was no light exiting the fiber connector, indicating a fracture in the connector.Fracture within the connector can occur during procedural handling of the fiber during setup or use.The connector fracture can result in an insufficient aiming beam or low laser energy output, up to a complete inability for the fiber to fire.A review of the device instructions for use (ifu) was completed, the ifu states: hold the fiber tip to a nonreflective surface and ensure that a circular red/green spot appears.If the spot is not circular, re-cleave the fiber.If the spot is weak or not visible, discard the device or return it to the supplier for replacement.Based on analysis and the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the fiber was connected to the holmium laser but there was no energy emission.The fiber was replaced to complete the procedure without patient complications.After that, the product was returned for analysis, and it concluded that there is an internal connector fracture.

• Brand Name: SLIMLINE EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma st 6; yokneam 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: 17084061
• Report Number: 2124215-2023-29227
• Device Sequence Number: 6181153
• Product Code: GEX
• UDI-Device Identifier: 17290109140169
• UDI-Public: 17290109140169
• 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): 09/27/2023

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: 04/03/2025
• Device Model Number: 0642-393-01
• Device Catalogue Number: 0642-393-01
• Device Lot Number: 0056480520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• 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: Unknown