Catalog Number 1105000026 |
Device Problem
Mechanical Jam (2983)
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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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Event Description
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This report summarizes 11 malfunction events, where it was reported the devices experienced steer mechanism is difficult to engage/disengage, brakes difficult to engage/disengage=.There was no patient involvement.
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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 was functionally/visually inspected in the field.The device was repaired and returned to use.10 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.
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Manufacturer Narrative
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The 10 devices that were pending evaluation were evaluated in the field and the issue was confirmed.The devices were repaired on site and returned to service.
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Event Description
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This report summarizes 11 malfunction events, where it was reported the devices experienced steer mechanism is difficult to engage/disengage, brakes difficult to engage/disengage.There was no patient involvement.
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Search Alerts/Recalls
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