| Catalog Number |
0748000000 |
| Medical Device Problem Code |
Mechanical Jam (2983)
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| Health Effect - Clinical Code |
No Clinical Signs, Symptoms or Conditions (4582)
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Type of Reportable Event
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Malfunction
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Additional 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.Evaluation results findings (components/results), 1 device: appropriate term/code not available / results pending completion of investigation.There was no remedial action taken.This device is not labeled for single use.
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Event or Problem Description
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between july 1-september 30, 2025.This report summarizes 1 malfunction event(s), where it was reported the device experienced steer mechanism is difficult to engage/disengage.No adverse consequence or clinically relevant delay in treatment was reported.
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Additional Manufacturer Narrative
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The device that was pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Evaluation results findings (components/results) 1 device: rod/shaft/mechanical problem identified.
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Event or Problem Description
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No new information.
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Search Alerts/Recalls
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