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	04/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, upon checking this fiber during first use, black spots were identified.The fiber was sterilized with ethylene oxide.During set-up the connector face was wiped clean.The procedure was completed with the same fiber without patient complications.Analysis of the returned fiber identified a connector fracture.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.The fiber was received for analysis in one piece.Microscopic inspection of the tip indicated it was degraded.Visual inspection of the fiber body did not exhibit any breaks.The fiber connector was in good condition; however, light was not passing through the face.The fiber was connected to console, and there was no aiming beam.The console read: error number 67: fiber expired, connect new fiber and resume operation.The reported black spots were not observed.Therefore, the reported complaint was not confirmed.The observed condition of no light exiting the connector could be a result of internal fracture in the connector.Fracture within the connector can occur during procedural handling of the fiber during setup, use, or reprocessing.The device history review (dhr) confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed.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.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 to this investigation.
Additional Manufacturer Narrative
E1 initial reporter phone number: (b)(6).Correction made to d3 manufacture name, manufacture address, manufacturer city, manufacturer zip/postal code, manufacturer country, manufacturer email, g1 mfr site facility name, mfr site address 1, mfr site city, mfr site state, mfr site zip, mfr site country, mfr site phone.Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.The fiber was received for analysis in one piece.Microscopic inspection of the tip indicated it was degraded.Visual inspection of the fiber body did not exhibit any breaks.The fiber connector was in good condition; however, light was not passing through the face.The fiber was connected to console, and there was no aiming beam.The console read: error number 67: fiber expired, connect new fiber and resume operation.The reported black spots were not observed.Therefore, the reported complaint was not confirmed.The observed condition of no light exiting the connector could be a result of internal fracture in the connector.Fracture within the connector can occur during procedural handling of the fiber during setup, use, or reprocessing.The device history review (dhr) confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed.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.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 to this investigation.
Event or Problem Description
It was reported that during the first use, upon checking it was found that there were black spots.The fiber was sterilized with ethylene oxide.During set-up the connector face was wiped clean.The procedure was completed with same fiber without patient complications.Analysis of the returned fiber identified a 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: 17288874
• Report Number: 2124215-2023-35435
• Device Sequence Number: 6319460
• 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: 06/09/2025
• Device Model Number: 0642-393-01
• Device Catalogue Number: 0642-393-01
• Device Lot Number: 0061550720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown