MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000 IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
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Model Number BI70000027120 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: bi71000483, serial/lot#: none.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 an imaging system.It was discovered by a manufacturer representative during planned maintenance (pm) that the system's covers, including the x-stage cover, were damaged.There was no patient involvement.
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Search Alerts/Recalls
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