Catalog Number 0620040660 |
Device Problems
Nonstandard Device (1420); Output Problem (3005)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2021 |
Event Type
malfunction
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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 there was loss of insufflation during procedure.
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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 there was loss of insufflation during procedure.
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Event Description
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It was reported that there was loss of insufflation during procedure.
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Manufacturer Narrative
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This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: not locking all the way.Probable root cause: software malfunction; power supply malfunction; insufflator design; unwanted movement of internal components / wiring; use error; electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge; mio board malfunction; bam board malfunction; lcd assembly failure; manufacturing / service error.The reported failure mode will be monitored for future reoccurrence.H3 other text: 81.
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Search Alerts/Recalls
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