Model Number 27026EF |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Foreign Body In Patient (2687); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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As per manufacturer incident report (b)(4) received from the factory in germany:
it was reported that the distal end of the catheter deflecting mechanism broke off during the procedure.The broken off part has not been found and an x-ray was taken without detecting the missing part in the patient.The broken off part could have remained in the patient's body.
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Manufacturer Narrative
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The affected device was requested for further investigation, but not returned yet.
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Manufacturer Narrative
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The device was evaluated on july 1st 2022.According to the visual inspection, the shaft is bent and traces of corrosion are visible on the entire instrument.It could be confirmed that the separated part of the insturment is missing.Based on the damage patterns and the investigation results, the most probable root cause is due to incorrect reprocessing, as the instrument was not properly dried.
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Event Description
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As per additional details provided in the final manufacturer incident report # (b)(4).Received from the factory in germany: the procedure was prolonged by approximately 10 mins as patient drapes, scrub trolley operating table and surrounding area checked.The actual operation results do not deviate from the planned operation results.
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Search Alerts/Recalls
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