Additional information received on 11apr2018: investigation - evaluation: visual inspection and functional testing of the returned device was conducted during the investigation.A review of complaint history, the device history record, instructions for use, quality control data, and specifications was also performed.One device was returned for investigation.The shipping tray was returned; however, the device was not in the shipping tray.The device was returned with the handle in the closed position and the basket formation in a partially opened position.The collet knob is tight and secure.The male luer lock adaptor (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 3.5 cm in length.A functional test was performed and it was noted that when the basket sheath is in the straight position the handle actuates the basket formation to the fully open and completely closed positions.But, when the basket sheath is coiled the device does not function.A visual examination noted the support sheath is bent 5 mm from nose of the mlla.Also noted, the basket sheath is damaged at the distal end of the support sheath.The device history record was reviewed and found no non-conformances related to the reported failure.A review of complaint history revealed this complaint is the only one associated with complaint device lot number 7737558.The instructions for use (ifu) provides the following information: caution: this device is conductive.Avoid contact with any electrified instrument.Caution: sterile if the package is unopened or undamaged.Do not use if package is broken.Important: enclose device in sheath before removing from tray/holder.Important: excessive force could damage device.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.Devices are inspected for damage and functionality prior to packaging.The complaint device was found to have a non-fully functioning basket due to sheath damage near the handle.Devices are inspected for damage and functionality prior to packaging.The observed damage likely occurred during handling/use of the device.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
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