Catalog Number 8065751901 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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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An ophthalmic surgeon reported that the first valved trocar cannula leaked upon initial insertion and the patient's eye collapsed.The surgeon inserted the infusion line into the trocar and the surgeon was able to pressurize the eye.The second and third valved trocar cannulas were observed leaking to the extent where there surgeon was unable to get the third cannula into the eye due to the eye being soft.Over time the leaking appeared to subside and the procedure was completed.There were no consequences to the patient.Additional information has been requested.The product sample is not available for evaluation.
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Manufacturer Narrative
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A review of the device history record indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there are four additional complaints associated with the lot for the reported issue.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.No sample was returned and the device history record review of the lot number provided indicated product was processed and released according to the product¿s acceptance criteria; therefore, the root cause for the defect experienced by the customer cannot be determined.Investigations have been initiated in order to improve the performance of the valves.Complaints are reviewed and monitored at regular intervals to evaluate effectiveness of actions taken.No additional action is required at this time.(b)(4).
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Search Alerts/Recalls
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