Catalog Number 6251000000 |
Device Problem
Difficult or Delayed Positioning (1157)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.2 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.There was no remedial action taken.This device is not labeled for single use.
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Event Description
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This report summarizes 2 malfunction events, where it was reported the device experienced difficult to maneuver (no tip).There were 2 events with patient involvement; no adverse consequences were reported.
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Search Alerts/Recalls
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