Two opened trocars were received for the report of difficulty inserting and removing instruments.The returned samples were visually inspected.One sample was conforming and one sample was non-conforming with a smashed hub, which does not contribute to the reported issue.Procedural residue was found in the cannula of each trocar.Both samples were then dimensionally inspected for cannula identification and were both found conforming.A review of the related device history records for the reported lot number indicates that the product was processed and released according to the products acceptance criteria.This evaluation does not confirm the difficulty inserting and removing instruments as reported by the customer.Procedural residue was found inside both cannulas received and evaluated by the investigation site.The returned samples were visually conforming for all attributes associated with the reported issue and were also dimensionally conforming for cannula identification, therefore, an exact root cause could not be determined as to why there was difficulty inserting and removing instruments through the returned samples.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.Furthermore, one probe sample was returned for evaluation for the report of the probe being unable to insert into a trocar cannula.A review of the related device history records for the reported lot number indicates that the product was processed and released according to the products acceptance criteria.The probe sample was visually inspected and was deemed conforming.The needle has a very slight bend that is considered acceptable.The needle middle, body side, and distal tip outside diameters were measured and deemed conforming.The probe needle was fit tested for function into a conforming trocar and the fit was deemed conforming.The complaint evaluation does not confirm the vitrectomy probe was not able to be inserted into a trocar.The probe needle dimensions were to specification and the probe was able to enter a trocar.The reason for why the customer could not get the probe to enter the trocar cannot be determined from this evaluation.(b)(4).
|