While pulling back the needle it did not retreat into the introducer."as per cc form: while pulling back the needle it did not retreat into the introducer product not coming back for inspection / the endoscope is damage.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Are images of the device or procedure available?no.If the report involves a kink or bend in the needle, where is this located on the device (handle end (proximal end) or patient end (distal end))? no.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? no.Please specify if yes.If the device was kinked below the sheath extender, was the kink observed before inserting the device into the scope? no.If the device is a procore needle, is the device damage located at the notch / core trap? n/a, yes, no if no, please specify where the damage is located: distal.Was gaining access to the target site difficult? no.Was the device used in a tortuous position? no.Was puncture of the target site difficult? no.Please describe the anatomical location of the intended target site (pancreas, stomach, lungs etc.).Stomach.A.If the lungs, which lymph node was being targeted? e.G.4r, 11r, 12l etc.Please describe the size of the intended target site.2 cm.If not with the device in question, how was the procedure performed and/or finished? no finish , endoscope was damage.Was the device damaged in packaging prior to removal? no.Was the device damaged on removal from packaging? no.Was force required to remove the device? no.Did the patient require any additional procedures as a result of this event? no.What intervention (if any) was required? was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? no.Were any other defects observed on the device prior to return (e.G.Kinks, bends, breaks etc.)? n no.If yes, please specify what was observed and where on the device it was observed.What is the scope manufacturer and model number that was used? eg-3870-utk pentax.Was resistance felt while inserting the device through the scope? no.Was the scope recently serviced / repaired? no.When was the issued with the product noted? on advancement of the sheath/needle or on needle retraction? retracting back the needle.Was the syringe used during the procedure, after the stylet was removed? no.Was difficulty experienced while retracting the needle? no.Was it possible to fully retract the needle into the sheath before removing the device from the patient? no.Was the endoscope in a flexed or twisted position at any time during the procedure? no.Was the stylet partially removed when advancing the needle into the target site? no.How many samples were obtained (passes completed) with this needle? one did any section of the device detach inside the patient? no.If yes, please specify: was there difficulty locking the sheath (or needle) in place or slipping experienced during use? no.Was there difficulty in attaching or detaching the device to the accessory channel port on the scope? no.When the needle tip was advanced into the target site was the distal scope position adjusted so as to strain or flex the needle? no.If an ebus procedure did the needle tip hit the cartilage rings of the trachea?.
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Pma/510(k) # k142688.Complaint device was not returned therefore a document based review will be performed.Prior to distribution, all echo-hd-19-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 manufacturing records for echo-hd-19-c of lot number c1853261 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current 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 c1853261.The notes section of the instructions for use, ifu0077-4, which accompanies this device instructs the user to inspect the device prior to 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".There is no evidence to suggest that the customer did not follow the instructions for use.A definitive root cause could not be determined from the available information.Although it has been advised target site was not difficult, it is possible the actual lesion was hard leading to the distal end of the needle to kink.A distal needle kink could lead to the retraction difficulties experienced.Complaint is confirmed based on the customer's testimony.According to the initial reporter, the patient did 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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