Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During the evaluation of the device, a functional test was performed by manipulating the handle.When the handle was being manipulated the forceps cups had significant delay when opening.Some attempts to open the cups fully were unsuccessful.When the cups were not fully open, the cups would close by handle manipulation.However, when the forceps cups would open fully, the cups would not close.The device was sent to the supplier for evaluation.The supplier provided the following evaluation: one device from the reported event was returned in a zip type bag with proof of decontamination.The device was tested for "would not open".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 slightly 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.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 "would not open" was confirmed; the device opens slightly 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.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.Note: exercising the handle while the forceps is coiled may result in damage to the performance characteristics of the forceps." prior to distribution, all captura biopsy forceps 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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During an esophagogastroduodenoscopy (egd), the physician used a cook captura serrated large forceps-spike.The forceps would not open once down the endoscope.The user discontinued used of the device, and another of the same device was used to complete the procedure.The device was received for evaluation on 05/18/2017.The cups of the forceps would not close after they were opened.There is a tactile broken feeling when the handle is manipulated.
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