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Model Number HAR36 |
Device Problems
Device Displays Incorrect Message (2591); Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/02/2015 |
Event Type
malfunction
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Manufacturer Narrative
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The complaint device was not returned to stryker sustainability solutions for evaluation; it was discarded by the facility.As the device reportedly emitted a hissing noise, which is indicative of tissue/fluid build up past the distal gasket, a malfunction mdr is being filed.The cause of tissue/fluid build up is damage to the distal gasket; action is being taken to address this issue.Tissue build up due to distal gasket damage can disrupt harmonic frequency and potentially reduce cutting ability.
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Event Description
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It was reported that during surgery the har36 ultrasonic scalpel had a "release pressure on jaws" error code and was making a hissing noise.There was no medical intervention or surgical delay, and the procedure was completed successfully.
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Search Alerts/Recalls
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