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Model Number ASU1200 |
Device Problems
Sticking (1597); Aspiration Issue (2883)
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Patient Problem
No Information (3190)
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Event Date 03/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The complaint was received and forward on to the manufacturing facility for investigation.The actual complaint product was requested, but not received for evaluation.The device history record for the reported lot has been reviewed for conformance to cardinal health specifications and the product does conform.The product is tested 100% for leaks specifically the ¿aspiration button¿ is depressed, opened and closed several times during the test for leaks, and visual integrity appears to be in conformance.Testing had been performed prior to final packaging and sterilization and met all requirements.We will continue to monitor and if the sample becomes available we will reopen the investigation.
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Event Description
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After several uses, the suction red switch remains depressed causing aspiration to continue.This causes a loss of pneumoperitoneum and a slowdown of the procedure.
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Manufacturer Narrative
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No sample was received for evaluation therefore we are unable to confirm the issue report.However, cardinal health has become aware of an issue in which the hydroline and pulse wave trumpet valves may not close properly, which could cause continuous suction.There is a remote possibility that inability to control suction during a procedure may result in loss of carbon dioxide in the abdomen, reduced visibility of the surgical site and potential injury to organs and body tissue.Cardinal health has issued a voluntary recall that was initiated on june 11th 2018.
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Search Alerts/Recalls
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