Catalog Number STS-JP-004 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that detached sensor wire occurred.The sensor was inserted into the abdomen on (b)(6) 2021 no product was provided for evaluation.The allegation and a probable cause could not be determined.No injury or medical intervention was reported.
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Event Description
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Subsequent to the initial mdr, additional information has been received.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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(b)(4).
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Event Description
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Post initial mdr submission the device evaluation was completed.The allegation was confirmed via product.The probable cause was unable to be determined via product.
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Search Alerts/Recalls
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