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

Model Number	0642-393-01
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Microscopic inspection of the tip indicated it had slightly degraded.Visual inspection of the fiber body did not identify any breaks or defects.Functional testing of the fiber identified there was no light exiting the connector face.This finding is indicative of a fiber fracture within the connector.It is probable that the fracture within the connector occurred during procedural handling of the fiber during setup or use.The instructions for use (ifu) states to 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 results, a conclusion code of cause traced to component failure was assigned which indicates an expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that during introduction of the fiber inside the patient, the metal tip of the fiber was overheating.There were no patient complications.No information was available regarding the procedure's outcome.Analysis of the returned fiber identified a fiber fracture within the connector.

• 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): LUMENIS LTD.; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17916293
• Report Number: 2124215-2023-56363
• Device Sequence Number: 2810565
• 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
• Report Date (Section B): 10/11/2023

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: 06/08/2025
• Device Model Number: 0642-393-01
• Device Catalogue Number: 0642-393-01
• Device Lot Number: 0061440720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2020
• 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 Age: 50 YR
• Patient Sex: Unknown
• Patient Weight: 70 KG