Catalog Number 8310.25G12 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/10/2021 |
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 particles/stains were noticed on the valve and the inserter of the trocar set included in the procedure pack.No patient harm or prolongation of the surgery occurred due to this event.
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Event Description
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We were informed that particles/stains were noticed on the valve and the inserter of the trocar set included in the procedure pack.No patient harm or prolongation of the surgery occurred due to this event.
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Manufacturer Narrative
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The complaint article was received for investigation.Visual inspection confirmed the foreign material as described in the reported event.As the origin of the material could not be clearly determined within d.O.R.C., the product will be analyzed in a external laboratory.As soon as results are available, the root cause investigation will be continued.
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Manufacturer Narrative
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In regard to this case, three cannula's from a disposable one step cannula system were received for investigation.Visual inspection confirmed the presence of a white substance on three cannula's and one inserter.Since the origin of the substance could not be determined within dorc, the product was sent to sgs laboratory in belgium for forensic analysis.Ftir reflection analyses revealed that the white substance was in fact precipitated vapor from the glue that is used during product assembly.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 an human error during quality control.Please note that actions have been taken to prevent re-occurrence of the reported event in the future.The risks and mitigations associated with the reported issue are identified in existing risk documents and no new risks were identified as part of this investigation.Trend analysis indicates that the product is performing within anticipated rates.Complaints will be closely monitored to identify any significant adverse trends.
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Event Description
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We were informed that particles/stains were noticed on the valve and the inserter of the trocar set included in the procedure pack.No patient harm or prolongation of the surgery occurred due to this event.
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Search Alerts/Recalls
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