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Model Number 408296 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/28/2021 |
Event Type
malfunction
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Event Description
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Related manufacturer report number: 3005334138-2021-00327.During the biopsy of rv myocardial tissue, the jaws on the forceps would not close.The device was replaced, but the same issue occurred with the second device.The case was unable to be completed due to this issue.There were no adverse patient consequences.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.The device was manufactured according to specifications as supported by the receiving inspection results.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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