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Model Number N/A |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/02/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The event is currently under investigation.A follow up report will be send upon conclusion.
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Event Description
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It was reported by the user facility that a patient underwent an ureteroscopy with stone extraction procedure.The device in use was an ngage nitinol stone extractor.The attending physician indicated that while attempting to extract a stone from the patient, the stone extractor would not reopen once the device was closed.However, the physician stated he was able to extract the stone successfully with no harm done to the patient or any additional procedures performed.No part of the device was left inside of the patient's body.The patient did not experience any adverse effects due to this occurrence.No further information was provided.
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Manufacturer Narrative
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A review of complaint history, device history record, documentation, quality control and manufacturing instructions was conducted during the investigation.The complaint device was not returned therefore physical examination of the device by the quality engineering and/or engineering departments could not be performed.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record revealed two non-conformances; however none of these were related to this failure.Based on the provided information a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
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Search Alerts/Recalls
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