MEDTRONIC NAVIGATION, INC. (LOUISVILLE) MALLEABLE SUCTION MEDIUM, STANDARD TIP; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
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Catalog Number 9735016 |
Device Problems
Device Stops Intermittently (1599); 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 05/19/2015 |
Event Type
malfunction
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Event Description
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A medtronic representative reported that, while in an ear, nose & throat (ent) procedure, the medium standard malleable stopped tracking mid-procedure.No further details were provided.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.
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Manufacturer Narrative
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Patient identifier field not sufficient to hold all digits, should read: (b)(6).Device manufacturing date is unavailable.This part was disposable and will not be returned to manufacturer for analysis.
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Manufacturer Narrative
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Correction to "common device name" and "usage of device."
additional information:
the site unplugged the suction and plugged it back in for trouble shooting.Mfg date now provided.
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Manufacturer Narrative
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Correction: it was discovered on 27-jan-2016, that an incorrect date was referenced in a previous supplemental 3500a submission.The reported date of 16-aug-2016 was reported incorrectly and should be 16-aug-2015.Statement in previous supplemental 3500a submission should read: ¿on 30-jun-2015, it was noticed that a coding error in mdr submissions from our facility resulted in the maude database incorrectly coding the devices related to our mdr submissions from 25-may-2015 to 16-aug-2015.The decision to wait until the database was corrected was made after consultation with the fda as advised by a consumer safety officer with the information analysis branch, division of post market surveillance, office of surveillance and biometrics.An it solution was implemented on 16-aug-2015.This mdr was submitted to correct the coding error.There is no new information to change the patient information, event description and/or manufacturer narrative that was previously reported.¿.
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