This complaint is associated with 3001845648-2017-00597 with the same procedure and same patient, after the first device was detected with tip bent , operator use the device in this pr to continue the procedure with tip bent again.With another new same device to complete the procedure.
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Pma/510(k) # k160229.(b)(4).Exemption number: e2016031.(b)(4).Lab evaluation:1 x echo-hd-25-ebus-p-c was returned to cirl for evaluation.Upon evaluation the following was noted the device was returned in its original packaging.The stylet was fully in place on return and there was no needle exposure.The needle advances and retracts without issue.The needle tip is bent at the notch.There are no cracks at the thumbscrew.The stylet can be advanced, little resistance is felt when doing so.The customer complaint is considered to be confirmed as the complaint was verified in lab as the needle tip was bent.Root cause: a possible root cause for the occurrence may be due to the needle penetrating a hard lesion which caused the needle tip to bend.Documents review: a review of the manufacturing records for echo-hd-25-ebus-p-c device of lot# c1328121 did not reveal any discrepancies that may have lead to this occurrence.There is no evidence to suggest that this issue effects the entire lot # c1328121; upon review of complaints this failure mode has not occurred previously with this lot # c1328121.Prior to distribution, all echo-hd-25-ebus-p-c devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Ifu review: the notes section of the instructions for use, ifu0110-5 which accompanies this device instructs the user to; "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use, it states in the ifu that an olympus ebus scope is intended to be used with the device".On review of the information provided, there is no viable evidence to suggest that the user did not follow the instructions for use.From the information provided: the patient did not experience any adverse effects due to this occurrence complaints of this nature will continue to me monitored for potential emerging trends.
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This complaint is associated with 3001845648-2017-00597 with the same procedure and same patient, after the first device was detected with tip bent , operator use the device in this pr to continue the procedure with tip bent again.With another new same device to complete the procedure.
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