The event occurred in new zealand.As stated by the customer: we have a customer that discovered a ceramic end from 27040xa inner sheath that had been left in a patient from a previous surgery 4 years ago.It has since been removed but our customer is asking if this is a known issue with the ceramic end of the inner sheath? it was confirmed that the information was not forwarded 4 years ago.Since the potential risk in case of reoccurrence is higher than remote, a report is required.Additionally, a report to the authority of new zealand is required.The item in question was not returned.According to the customer description, this process is a user error.On the one hand, the reason is improper handling (see note ifu) and the item must be checked for damage before each use.Since the age of the socket is not known, the material may have caused material fatigue due to high age and the resulting number of reprocessing (refer to the instructions for use, 97000126; version: 3.0_03/2019) the event is filed under internal karl storz complaint id: (b)(4).
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