Investigation: x-initiated manufacturer's investigation, x-no sample returned and x-review dhr.Analysis and findings: quality engineering, research and development, marketing, and product surveillance conducted an investigation into 4 advincula soft koh-efficient product complaints (b)(4) from kaiser, where small fragments (~ 1 mm) of the soft cup either became damaged or melted, disengaging from the cup.This evaluation was based on a review of complaint history, a device history file review, and photographs of the applied advincula soft koh-efficient products.A review of complaints indicated that there were four similar complaints on file for this reported condition.A review of the device history record for lot no.227-18 and 222-18 indicated that the units were released meeting all quality release specifications at the time of manufacture and did not reveal any abnormalities.A review of the photographs received confirmed the reported condition.Replication of the reported condition may be attributed to technique during a colpotomy, in which constant movement of the electrosurgical unit (esu) cutting tip is necessary.For example, if the end user does not keep the esu tip moving and remains in one place on tissue for an extended period of time, the advincula soft cup material may begin to melt.Correction and/or corrective action: none.Reason: the product met the required release specifications per dhr review.No re-training required.Coopersurgical is exploring other potential soft materials with a higher melting temperature - reference capa 722.Was the complaint confirmed? yes.Review and closure capa required? #: 722.Preventative action activity: reference capa 722.Reference e-complaint-(b)(4).Re: subject report number: (b)(4).
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