Model Number TRIMARK TD 13MR |
Device Problems
Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.
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Event Description
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It was reported that, during a biopsy procedure, when placing the biopsy marker the radiologist deployed the marker as usual.When the marker device was removed from the breast it was noted the marker was stuck in the aperture.Redeployment was not attempted.No injury reported.
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Search Alerts/Recalls
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