Catalog Number 625705550002 |
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 10/01/2023 |
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.1.Device is 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 1 malfunction event, where it was reported the device experienced difficult to maneuver unit which does not result in a tip.There was no patient involvement.
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Event Description
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This report summarizes 1 malfunction events, where it was reported the device experienced difficult to maneuver unit which does not result in a tip.There was no patient involvement.
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Manufacturer Narrative
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The device pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Section h codes have been updated to reflect this.
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Search Alerts/Recalls
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