Model Number 26432020-1 |
Device Problem
Inflation Problem (1310)
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Patient Problem
Pulmonary Emphysema (1832)
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Event Date 04/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
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Event Description
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It was reported that there were insufflation problems during surgery and pressure check was needed.The surgery was completed successfully.The patient suffered a pulmonary emphysema and needed additional hospitalization after surgery.
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Manufacturer Narrative
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The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
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Manufacturer Narrative
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Investigation revealed that the device functions as intended and the failure described by customer cannot be reproduced.A contamination in the entire pressure control unit was detected.It is possible that the valve got stuck in the actuator due to dirt in the pressure control unit and thus led to an increase in pressure in the patient.However, this could not be verified by the tests.The contamination/dirt is caused by the hospital co2 supply unit.The instruction for use stated that a a functional test for proper operation is required prior to each surgical procedure and in case of any substantial deviations, to inspect the unit by an authorized technician before further use.In addition the device ist about 18 years old and the service manual recommends a preventive maintenance and safety check at least once a year.According to our records the device has not been returned for repair or service since.Review of the complaint history revealed that no similar incidents have been filed against this article number since 2005.Based upon the investigation results, the root cause of the reported issue can be traced back to a usge-related failure.Specifically, it is assumed that the interruption of function was caused by contamination/dirt that was found inside the device.The event is filed under internal karl storz complaint id: (b)(4).
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Search Alerts/Recalls
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