Additional information: d4 - batch and expiration date.D9 - product return.H3 - yes, evaluation.H4 - manufacture date.H6 - codes updated.Investigation results: visual inspection: the clip cassette exhibits a broken-off latch on the plastic housing.Furthermore, a deformation is noted on the tip of the slider sheet.A clip jam could not be detected.Batch history review: 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 - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, additional medical intervention.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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