The 510(k) number: k142688.(b)(4).This complaint file (b)(4) was opened as second failure mode (distal needle kink) noted during the device investigation for (b)(4).Device evaluation: the echo-hd-3-20-c device of lot number c1419281 involved in this complaint was returned for evaluation, with original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was conducted.Complaint is confirmed as the failure was verified in the laboratory.Additional information was received as follows: 1.If the report involves a kink or bend in the needle, where is this located on the device (handle end or patient end)? - patient end.2.Please describe the location in the body for the intended target site (pancreas, stomach, etc).- upper posterior wall of gastric corpus.3.Please describe the size of the intended target site.- asku.4.What is the endoscope manufacturer and model number that was used with this device? - olympus / model unknown.5.Was gaining access to the targeted site difficult? - no.6.Was the endoscope in a flexed or twisted position at any time during the procedure? - no.7.Was needle penetration of the targeted site difficult? - no.8.Was the stylet in place inside the needle when advancing into the targeted site? - yes.9.How many biopsies were obtained with use of this needle? - twice.10.Did any section of the device detach inside the patient? - no.11.If not with the device in question, how was the procedure performed and/or finished? - with another cook's needle.The device related to this occurrence underwent a laboratory evaluation on the 18th july 2018.On evaluation of the returned device, the device was returned with original packaging.Distal needle kink was noted, effects are stylet will not go past kink and needle will not retract.Syringe was not returned.Needle will not retract and stylet cannot be placed in fully.Visual and functional checks were completed.Break on the needle midway 576 mm from distal tip was noted.Visible damage on sheath where break occurred.Length of broken needle is 565 mm.Root cause: a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.However it is possible that due to needle breakage midway as reported and investigated within (b)(4) the needle could not be fully retracted or stylet fully inserted.Therefore needle kink distally.It may be noted that according to packaging insert, there is no evidence to suggest that the customer did not follow the packaging insert.Document review: a review of the qc records did not reveal any issues which could have contributed to this complaint issue.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 (b)(4).Standard operating inspections include: ¿check for visual defects, debris, loose or embedded foreign materials, rough or sharp edges, bends or kinks.¿ all products and packaging are 100% inspected for visual irregularities such as holes, dents, kinks or tears.Additional inspections carried out in the manufacturing process: ¿measure the needle extension with the outer handle positioned at reference mark 8 and with the sheath in a straight position.The needle extension should be as per the drawing and free from any damage / kinks.Verify the needle fully retracts into the sheath¿ a review of the manufacturing records for echo-hd-3-20-c device of lot# c1419281 did not reveal any discrepancies that could have contributed to this complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1419281; upon review of complaints this failure mode has not occurred previously with this lot # c1419281.Summary: complaint is confirmed as the failure was verified in the laboratory.The risk was determined to be no risk (category iii).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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