Pma/510(k) # k142688 the echo-hd-3-20-c device of lot number c1617971 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 16oct2019.There was a proximal break below the sheath extender.There was a unevenness felt approximately 8cm from the needle tip, the needle penetrated the target site 30 time per biopsy and this was potentially the cause of the needle breaking.As a result this possibly contributed to the unevenness felt in the needle during the lab evaluation there was a distal kink at the notch area, as per information provided, this was because the user accidentally bent the needle tip after the procedure.Prior to distribution, all echo-hd-3-20-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.A review of the relevant manufacturing records (c1617971) revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1617971.There is no evidence to suggest that the customer did not follow the instructions for use."visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to excessive force during the 60 scrolls that were made.Complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
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The user advanced echo-hd-3-20-c/lot c1617971 into olympus's uct260.Biopsy of stomach smt was performed three times.On the first and the second biopsy, 60 scrolls (= 30 times of needle advancement per biopsy) were made.Then, the third biopsy was performed but the needle became unable to move by handle manipulation and the needle tip could not be retracted inside the sheath during the third biopsy.The procedure was continued with another device(boston's acquire) and completed successfully.There have been no adverse effects to the patient reported.
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