Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Corrected information: information that was received on 01apr2020, but inadvertently not reported on the first follow up mdr: d4: expiration date and h4.Investigation ¿ evaluation it was reported on 03/30/2020 of an incident involving a ncircle tipless stone extractor.The device reportedly was found to have a damaged handle during a transurethral lithotripsy procedure on 03/19/2020.Further communication with the user facility clarified that another ntse-015115 device was used to complete the procedure.No adverse effects to the patient.A visual inspection and functional testing of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, and quality control data.One ncircle tipless stone extractor was returned for investigation.Visual inspection of the returned device noted the device was returned with the handle in the open position and the basket formation in the closed position.The mlla (male luer loack adapter) and collet knob were tight and secure.The polyethylene terephthalate tubing [pett] measured 2.5 cm in length.The cannulate handle was protruding the collet knob by approximately 1cm.The support sheath was bowed.Functional testing determined the handle does not actuate the basket formation.The handle was then disassembled.Further examination noted the cannulated handle was broken at the junction of the handle and the coil assembly.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precaution: enclose the device in the sheath before removing from the tray/holder.Precaution: do not use excessive force to manipulate this device.Damage to the device may occur.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The returned device was found to have a basket that was closed and could not be opened.The device was found to be damaged in two locations: the proximal end of the cannulated handle was protruding from the handle and the distal end was broken where it connects to the basket coil assembly.It appears the distal end of the cannulated handle was damaged first, preventing the basket from opening.Force applied to open the basket after the distal end of the cannulated handle was damaged forced the proximal end out of the handle.Extractors are inspected multiple times for damage and proper functioning during manufacturing and quality control checks.The extractors are also packaged with the basket open, indicating the basket was closed by the user.It is possible the observed damage occurred during unpacking or subsequent handling, but there is no provided evidence related to device handling, therefore the cause for the issue could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.
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