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Model Number HAR36 |
Device Problems
False Alarm (1013); Loss of Power (1475); Device Stops Intermittently (1599)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/20/2015 |
Event Type
malfunction
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Manufacturer Narrative
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The complaint device was returned to (b)(4) for evaluation.Inspection of the returned device revealed clinical use including biological material on the distal tip and indention in the teflon pad.The shaft rotation and the jaw actuation of the device were found to be acceptable.The device was connected to a generator and passed the initial testing.During testing on a test medium, various error messages were emitted by the generator.The device was examined further and a build up of tissue/fluid was noticed along the rod which can disrupt harmonic frequency and reduce cutting ability.The distal gasket on the rod was examined and revealed signs of damage and wearing of the gasket lip which would allow fluid/tissue to rise up the rod.The device did not operate as a result of a build up of fluid/tissue along the distal end of the inner rod.Tissue build up due to distal gasket damage can disrupt harmonic frequency and potentially reduce cutting ability.The reported event will continue to be monitored through post market surveillance.
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Event Description
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It was reported that har36 device had either intermittent signals, false alarms, or shut off.There was no patient injury or medical intervention, and extended procedure time reported was minimal.
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Search Alerts/Recalls
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