Catalog Number 6252000000 |
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 04/01/2021 |
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.59 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.2 devices are pending evaluation.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 61 malfunction events, where it was reported the devices experienced difficulty maneuvering (no tip).There was no patient involvement.
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Event Description
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This report summarizes 60 malfunction events, where it was reported the devices experienced difficulty maneuvering (no tip).There was no patient involvement.
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Manufacturer Narrative
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Upon evaluation of one of the final devices, it was determined the device was experiencing cosmetic damage, which is not reportable.The count of events has been updated to reflect this.The final device was not made available for evaluation; the reported issue was not confirmed.
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Search Alerts/Recalls
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