Catalog Number 2281.AD06 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The complaint is under investigation.
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Event Description
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We were informed that the shaft of the instrument came loose from the handle.No actual patient harm occurred.
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Manufacturer Narrative
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In regard to this event one backflush instrument was received for investigation.Visual inspection of the returned instrument revealed severe damage to the handle and the so-called reservoir front fix.Close examination of the damaged parts showed markings that were consistent with damage that would be the result of an attempt to take the instrument apart; possibly with the intention of cleaning it for reuse.Device history record review revealed no deviations.It should be noted that all backflush instruments are visually inspected prior to being released for distribution.A database search showed that no similar complaints have been reported on this specific lot previously.Based on the investigation performed, it was determined that the reported event is attributable to damage caused by an attempt to use the device more than once while it is designed for one use only as indicated on the product labelling.
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Event Description
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We were informed that the shaft of the instrument came loose from the handle.No actual patient harm occurred.
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Event Description
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We were informed that the shaft of the instrument came loose from the handle.No actual patient harm occurred.
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Manufacturer Narrative
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The complaint is under investigation.No corrective or preventive actions can be implemented until the investigation has been completed.Dhr review performed did not reveal any anomalies.Since it has been indicated that the product will be returned the investigation will be continued when the device is available for examination.
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Manufacturer Narrative
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The complaint is under investigation.No corrective or preventive actions can be implemented until the investigation has been completed.Please be informed that the investigation regarding this event is ongoing.
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Event Description
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We were informed that the shaft of the instrument came loose from the handle.No actual patient harm occurred.
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Search Alerts/Recalls
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