Model Number 021251-29A |
Device Problems
Fracture (1260); Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
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Patient Problem
Awareness during Anaesthesia (1707)
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Event Date 07/06/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Event took place in (b)(6) and has been reported through (b)(4).Currently, the data is poor and the device has not been sent back/ analysed.As soon as further data will be available, a follow up report will be sent in to the agency.
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Event Description
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Internal report number: (b)(4).Summarizing translation of user's narrative: upon difficult unsuccessful puncture, sprotte needle navigated heavy, removed, needle tip got lost, surgical intervention to retrieve fragment.
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Manufacturer Narrative
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Based on risk assessment and clinical evaluation file is considered as closed.
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Event Description
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(b)(4).Summarizing translation of user´s narrative: upon difficult unsuccessful puncture sprotte needle navigated heavy, removed, needle tip got lost, surgical intervention to retrieve fragment.Patients bmi high (165cm/125kg).
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Search Alerts/Recalls
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