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

Model Number	0642-393-01
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during first use of this fiber, black spots were identified during testing.The procedure was completed with this device.Analysis of the fiber identified a fiber internal connector fracture and a fiber body kink.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Microscopic analysis of the fiber tip indicated it was degraded.Visual analysis identified a kink in the fiber body, the connector exhibited burn marks on the surface and no light was passing through the face, indicating a possible internal connector fracture.This can result in an insufficient aiming beam or low laser energy output, up to a complete inability for the fiber to fire.In addition, the observed burn marks on a connector face can be caused by prolonged use of the device and/or the blast shield being damaged.The device instructions for use (ifu) was reviewed.The ifu contains instructions for device preparation and use.The ifu states: inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the device; return it to the supplier for replacement.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 (see postoperative instructions for details).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 as it was determined that the identified fiber break is an expected or random component problem without any design or manufacturing issue.
Event or Problem Description
It was reported that during first use of this slimline fiber, black spots were identified during testing.The procedure was completed with this device.Analysis of the fiber identified a fiber internal connector fracture and a fiber body kink.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Microscopic analysis of the fiber tip indicated it was degraded.Visual analysis identified a kink in the fiber body, the connector exhibited burn marks on the surface and no light was passing through the face, indicating a possible internal connector fracture.This can result in an insufficient aiming beam or low laser energy output, up to a complete inability for the fiber to fire.In addition, the observed burn marks on a connector face can be caused by prolonged use of the device and/or the blast shield being damaged.The device instructions for use (ifu) was reviewed.The ifu contains instructions for device preparation and use.The ifu states: inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the device; return it to the supplier for replacement.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 (see postoperative instructions for details).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 as it was determined that the identified fiber break is an expected or random component problem without any design or manufacturing issue.

• 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: 17502948
• Report Number: 2124215-2023-41892
• Device Sequence Number: 2395051
• 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): 09/28/2023

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: 07/25/2025
• Device Model Number: 0642-393-01
• Device Catalogue Number: 0642-393-01
• Device Lot Number: 0063980820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2020
• 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