Catalog Number 1251QCS |
Device Problems
Positioning Failure (1158); Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/28/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.
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Event Description
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It was reported that the cartridge malfunctioned and the seeds did not deploy.
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Manufacturer Narrative
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The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "in the event the quicklink loader or cartridges become inoperable due to damage or malfunction, any or all components may be removed from the cartridges and implanted manually.Pushing the dispense button does not eject any items or produces a partial dispense." (b)(4).
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Event Description
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It was reported that the cartridge malfunctioned and the seeds did not deploy.
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Search Alerts/Recalls
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