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

Model Number	0642-394-01
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Analysis of the returned fiber confirmed the reported clinical observation as analysis identified a connector fracture.The fiber was received in one piece.Microscopic inspection of the fiber tip indicated it was degraded.Laser fibers are consumable devices and expected to degrade with use.Analysis identified there was no light exiting the connector face, indicating an internal connector fracture.During the functional testing, it was identified that there was no aiming beam.The console displayed a message that read: error 65.The observed condition of no light exiting the connector can be a result of an internal connector fracture.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.The ifu states: 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.Hold the fiber tip to a non-reflective surface and ensure that a circular red/green spot appears.If the spot is not circular, cleave the fiber.If the spot is weak or not visible, discard the fiber or return it to the supplier for replacement.Based on 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, during preparation of the procedure, the slimline fiber did not work the first time it was used.The procedure was completed using another fiber without patient complications.Analysis of the returned device identified a fractured connector.
Event or Problem Description
It was reported that, during the procedure, the fiber malfunctioned after about 10 minutes of use, with blackening of the tip making it unable to continue using the fiber.The procedure was completed using another fiber without patient complications.Analysis of the returned device identified a fractured connector.
Additional Manufacturer Narrative
A2 age at time of event: additional information was received which corrected the patient age.B3 date of event: additional information was received which corrected the date of event.B5 describe event or problem: additional information was received which corrected the event description.Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Analysis of the returned fiber confirmed the reported clinical observation as analysis identified a connector fracture.The fiber was received in one piece.Microscopic inspection of the fiber tip indicated it was degraded.Laser fibers are consumable devices and expected to degrade with use.Analysis identified there was no light exiting the connector face, indicating an internal connector fracture.During the functional testing, it was identified that there was no aiming beam.The console displayed a message that read: error 65.The observed condition of no light exiting the connector can be a result of an internal connector fracture.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.The ifu states: 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.Hold the fiber tip to a non-reflective surface, and ensure that a circular red/green spot appears.If the spot is not circular, cleave the fiber.If the spot is weak or not visible, discard the fiber or return it to the supplier for replacement.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: SLIMLINE EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; 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: 20683544
• Report Number: 2124215-2024-71453
• Device Sequence Number: 7196949
• Product Code: GEX
• UDI-Device Identifier: 17290109140176
• UDI-Public: 17290109140176
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: 0642-394-01
• Device Catalogue Number: 0642-394-01
• Device Lot Number: 0014270323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male