Investigation ¿ evaluation: a review of the functional test, instructions for use (ifu), specifications, complaint history, device history record, manufacturing instructions, and quality controls were completed, and visual inspection of the returned device was conducted during the investigation.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.One device was returned for investigation.The device was returned with the unidex handle (udh) in the closed position and the basket formation was partially open.The udh handle would actuate the basket formation to the fully open, but when closing, the basket formation would only partially close.It was noted that when the handle knob is pushed to the end of the slide, the basket formation closes completely.The collet knob was tight and secure.The support sheath is adhered securely to the basket sheath.The device is shipped with an instruction for use (ifu) that describes the intended use.A visual examination of the device noted the basket sheath has kinks, one at 4 cm from the support sheath and another 33 cm from the support sheath.A review of the non-conformance data revealed 1 non-conformance which was not related to the complaint condition.Based on the provided information a definitive root cause cannot be established or reported at this time.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
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