Catalog Number 0620040610 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/20/2018 |
Event Type
Injury
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that the insufflator was producing high level of co2.The case was converted to open procedure and completed successfully.
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Manufacturer Narrative
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The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: excessive co2.Probable root cause: pressure sensor malfunction / out of calibration.Software malfunction.Use error.System design.Unwanted movement of internal components / wiring.Insufflator operated at least-favorable environmental conditions for an extended period of time.Pressure button does not disengage.The failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that the insufflator was producing high level of co2.The case was converted to open procedure and completed successfully.
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Search Alerts/Recalls
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