Catalog Number 8065753106 |
Device Problems
Detachment of Device or Device Component (2907); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/04/2022 |
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 nurse reported the strange aspiration noise which led to investigate the cutter and the aspiration line was not connected during surgery.After further investigation, all three lines were easily removed from the hypervit tip.There was broken/disconnected aspiration line.There was no patient harm.
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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 was received for this investigation.However, a full evaluation was unable to be performed as no sample was returned.Though the customer's complaint was confirmed by the photograph of the probe, the definitive root cause of 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 no root cause could be established.No adverse trends have been observed associated with the reported product and event.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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