Model Number 9733856 |
Device Problems
Human-Device Interface Problem (2949); Output Problem (3005)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: other relevant device(s) are: product id: 9733575, serial/lot #: unk.A medtronic representative went out to the site and found a hardware failure noting that the camera localizer was not responding.They replaced the camera localizer cable to main cart, and now the localizer is working now and instruments tracking correctly.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information regarding a navigation system used outside of a procedure.It was reported that the site was having intermittent "localizer not connected " behavior issues.There was no patient involved.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Initial reporter was a biomed from the site.Name of initial reporter unknown at the time of report.The cable 9733575 ext scu to r/a psu (170928) was returned for analysis.Analysis found that the cable had been pinched near the right angle connector, but was otherwise intact.The cable passed a continuity test with no opens or shorts detected.There was no problem found.(b)(4).If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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