DEROYAL INDUSTRIES, INC. DEROYAL; TUBING/TUBING WITH FILTER, INSUFFLATION, LAPAROSCOPIC
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Model Number 28-0207 |
Device Problem
Output Problem (3005)
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Patient Problem
Unspecified Respiratory Problem (4464)
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Event Date 01/17/2022 |
Event Type
malfunction
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Event Description
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It was found that the deroyal laparoscopic insufflation tubing with adapter does not have the same connection to confirm in the stryker pneumosure xl high-flow insufflation that a good seal is present.Thus, accurate pressure monitoring of insufflation is not able to be monitored.During procedure, stryker insufflator did not regulate to the specified pressure, increasing to the point the patient experienced respiratory issues.Procedure was aborted.
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Event Description
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It was found that the deroyal laparoscopic insufflation tubing with adapter does not have the same connection to confirm in the stryker pneumosure xl high-flow insufflation that a good seal is present.Thus, accurate pressure monitoring of insufflation is not able to be monitored.During procedure, stryker insufflator did not regulate to the specified pressure, increasing to the point the patient experienced respiratory issues.Procedure was aborted.Update: upon further investigation by the reporting facility, the clinical staff realized that the issue is not with the deroyal tubing, but rather the adapter that stryker has for the pneumosure insufflator.Deroyal has been informed of these new findings.
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Event Description
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It was found that the deroyal laparoscopic insufflation tubing with adapter does not have the same connection to confirm in the stryker pneumosure xl high-flow insufflation that a good seal is present.Thus, accurate pressure monitoring of insufflation is not able to be monitored.During procedure, stryker insufflator did not regulate to the specified pressure, increasing to the point the patient experienced respiratory issues.Procedure was aborted.Update: upon further investigation by the reporting facility, the clinical staff realized that the issue is not with the deroyal tubing, but rather the adapter that stryker has for the pneumosure insufflator.Deroyal has been informed of these new findings.
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