Catalog Number 8065752201 |
Device Problem
Suction Failure (4039)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported there was no vacuum during cataract procedure.The procedure was completed and there was no harm to the patient.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information was provided indicating the surgeon opened new fluid management system (fms) cassette.
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Manufacturer Narrative
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A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.In-process controls are established to ensure each final assembled cassette is verified that all required tests have been performed and all acceptance criteria are met prior to release.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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One used sample was returned for evaluation.Inspection of the sample found no obvious defects that would have contributed to the reported event.The fluidics management system (fms) cassette was tested on a console, primed and tuned with the ultrasonic hand piece successfully and could achieve maximum vacuum.No system message was generated during functional testing.No fluid or air leaks, and no cracks were observed from the connectors.The irrigation and aspiration flow rates were measured and found to be within specifications.Fluid flowed from the balance salt solution (bss) bottle through the irrigation path continuously, no fluidic anomalies were observed.No occlusion or obstruction was identified during inspection and functional testing.The root cause of the customer's complaint could not be established as the returned fms cassette was evaluated and met specifications.After investigation of this complaint, it has been determined that this sample functioned per specifications; therefore, no corrective action is required at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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