The physician did 1 session successfully.But after 2nd session, the stylet didn¿t come into the hole.So the nurse didn¿t obtain the samples on 2nd session.After this situation, the physician used another procore needle and case finished successfully.Lab evaluation complete on 24th march 2022: visual inspection: stylet returned separately.Functional inspection: sheath extender able to retract and advance without issue.Needle handle able to advance and retract without issue.Distal end of needle examined and no issue observed.Attempted to insert the stylet but unable to pass just below the sheath extender.Needle removed from the device and needle break observed (below the sheath extender).Did any section of the device remain inside the patient body? no.Did the patient require any additional procedures due to this occurrence? no.Did the product cause or contribute to the need for additional procedure(s)? no.Were there any adverse effects on the patient due to this occurrence? no.Did the product cause or contribute to the adverse effect(s)? 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))? please describe the location in the body for the intended target site (pancreas, stomach, lungs etc.).Pancreas if the lungs, which lymph node was being targeted? e.G.2r, 2l, 4r, ao, ar, 11ri, 11s etc.Please describe the size of the intended target site.1.5cm if not with the device in question, how was the procedure performed and/or finished? the physician finished with 1 core samples at 1st session.Was the device used in a tortuous position? no.Are images of the device or procedure available? no.Was the device damaged in packaging before removal? nurse already checked.Was the device damaged on removal from packaging? no.Was force required to remove the device? no.For complaints occurring during use (once in contact with endoscope) also ask: what is the endoscope manufacturer and model number that was used? olympus , gf-uct-180.Was the scope recently serviced / repaired? no.Was resistance felt while inserting the device through the scope? no.When was the issued noted? e.G.On advancement of the sheath/needle or on needle retraction? 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 before removing the needle from the patient? yes.Was gaining access to the target site difficult? no.Was the endoscope in a flexed or twisted position at any time during the procedure? no.Was puncture of the target site difficult? no.Was the stylet partially removed when advancing into the target site? no.How many samples were obtained with this needle? 2 sessions finished successfully but 1 samples were obtained at the 1st needle because of the stylet problem.Did any section of the device detach inside the patient? no.If the device was kinked below the sheath extender, was the kink observed before inserting the device into the scope? n/a.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 of the leur lock to the scope? no.If the device is a procore, is the kink located distally at the notch / core trap? no.
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Pma/510(k) # k142688; device evaluation: 1 unit of lot c1881775 of echo-hd-3-20-c was returned opened in its original packaging.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on 24 march 2022.A proximal needle break below the sheath extender was observed.Document review including ifu review prior to distribution, all echo-hd-3-20-c devices are subjected to functional checks and visual inspection to ensure device integrity.A review of the manufacturing records for echo-hd-3-20-c of lot number c1881775 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has previously occurred with the current lot number.This was with related complaints pr 352822.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1881775.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 the user did not follow the ifu.Root cause review: a definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the device breaking during removal of the device from the endoscope after the first session.A capa (pr 217973) has been initiated to document and track the actions taken to investigate and to address kinking or breaking of the sheath at the sheath/sheath extender junction.Summary: 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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