Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.During the evaluation of the returned device, the device was functionally tested.When the handle of the device was manipulated the forceps cups will open, but they will not close.Several attempts were made to close the forceps cups, but they were unsuccessful.The device was then placed down an olympus gif-q20 (2.8 mm channel) endoscope.The endoscope was put in a torturous path.When the handle was manipulated the device would open, but the cups would not close.The device was sent back to the supplier for evaluation.During a visual inspection of the distal tip of the device, the sheath is extended over the forceps cup housing.The supplier provided the following evaluation: one device from the reported event was returned in a zip type bag with proof of decontamination.The returned device from the reported event was tested for "would not close".During functional testing, with the device coiled into three (3) 8" loops, it was confirmed that the device would not operate properly when the handle was manipulated.The device opens but does not close.Upon further investigation and disassembly of the device tip, it was noted that the device has a butt joint that has broken at the solder connection.The reported defect was confirmed.Additional vision inspection of the device also noted that at the distal tip of the device the sheath was extended over the forceps cup housing.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: the customer experienced issue of "difficulties with device" was confirmed; the device opens but does not close.The device has a butt joint that has broken at the solder connection.The root cause is a butt joint with a broken control wire / link wire solder joint.The supplier is currently working on improvements to create a more robust soldering process to prevent solder joints from breaking.Additional inspection of the device also noted that at the distal tip of the device the sheath was extended over the forceps cup housing.The root cause for the sheath being extended over the forceps cup housing was undetermined.The instructions for use state the following in regards to product inspection: "beginning at the handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable.Open and close the cups to verify smooth handle operation and appropriate cup action.Become familiar with the amount of handle movement required to operate the cups.If any irregularities are noted, do not use.Exercising the handle while the forceps is coiled may result in damage to the performance characteristics of the forceps." prior to distribution, all cook captura serrated large forceps-spike are subjected to a visual inspection and functional test to ensure proper workability.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
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