Investigation results: visual inspection: during visual examination of the complaint sample a clip jam was noted.The slider sheet was found to be deformed.Furthermore, the nose of the plastic housing was found to be broken-off.Batch history review: aesculap ag was able to identify batches that were delivered to the customer.This concerns the batches concerns the batches with internal reference number (b)(4).The device quality and manufacturing history records have been checked for all leading device(s) lot numbers and the products found to be according to specifications valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - malfunction (not later than 30 days).The assessment for the reportability of this malfunction was based on review of applicable risk analysis.Conclusion/preventive measures: based upon the above-mentioned investigation results, a definitive root cause cannot be established.The results show no hints for product or manufacturing error.Based upon investigation results, a capa is not necessary.
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