Catalog Number 03.161.028 |
Device Problems
Incorrect Measurement (1383); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/07/2014 |
Event Type
malfunction
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Event Description
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Device report from synthes (b)(4)reports an event in (b)(6) as follows: it was reported the measuring stick depth gauge measures incorrectly and gets "loose".This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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