Model Number 0620040610 |
Device Problems
Decrease in Pressure (1490); Increase in Pressure (1491); Insufficient Information (3190)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/11/2021 |
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 the procedure was converted to open surgery.
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Event Description
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It was reported the the procedure was converted to open surgery.
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Manufacturer Narrative
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Alleged failure: during case, the pressure was set to 15 but actual was 0-20 and would jump/drop in a couple of seconds.Flow was doing the same.Tried a different tube set but did not help.Brought in another insufflator and the same thing happened.After about 10 minutes of troubleshooting and no success, surgery went from laparoscopic to open.Per rep about 15-30 min of delay.Occurred at 9:30am cst.Unknown at this time about success of case.Salesforce case number: (b)(4) case successful after open per rep the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.There is no probable root cause in relation to the complaint as there were no errors or observances which occurred during the functional testing of the unit.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
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Search Alerts/Recalls
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