Catalog Number RB4892E / 0120814ABS |
Device Problem
Failure to Cut (2587)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Manufacturing records, including quality inspection documents, were reviewed and found to be conforming.No investigation possible since the device has not been returned.If additional information becomes available, a follow-up report will be submitted.
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Event Description
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The second week of (b)(6), the customer reported that an rb4892e ruggles stealth micro ejector kerrison rongeur stopped cutting within 3-4 months of usage.Additional information received on 01/01/2018 and 02/14/2018 indicated that the patient had been prepped for laminectomy.There was a 30-minute delay because a different product had to be opened.There was no patient injury.
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Manufacturer Narrative
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As per the specification developer, the device was returned by the user to the specification developer, who tested it for cutting performance.The device conformed to defined specifications and was resent to the user.Complaint cannot be confirmed.
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Search Alerts/Recalls
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