Catalog Number 8065750833 |
Device Problem
Blocked Connection (2888)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/25/2019 |
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.(b)(4).
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Event Description
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A surgeon reported the cassette's tubing was blocked during a cataract procedure.The product was replaced with another one and the procedure was completed with no harm to the patient.Additional information was requested; however, none has been received to date.
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Manufacturer Narrative
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The lot complaint history was reviewed; this is the first complaint for the finish goods lot and first for this issue for this lot.The device history record shows the product was released per specifications.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.Visual inspection or functional testing could not be conducted in order to ascertain the failure mode for the consumable device.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.After an investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and a root cause evaluation could not be performed.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The wet returned sample was visually inspected and the drain bag was detached from the cassette cover due to saturation.A calibrated console was used to sample and the cassette primed and tuned with the ultrasonic handpiece successfully and could achieve maximum vacuum.No system message was generated, no fluid or air leaks, and no cracks were observed on the connectors that would have contributed to the reported event.The irrigation and aspiration flow rates were measured and found to be within specifications.Fluid flowed from the bss bottle to the irrigation and aspiration manifolds and continuously to the cassette housing.No occlusion or obstruction was observed 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.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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