Occupation: unknown.Investigation evaluation: our laboratory evaluation of the product confirmed the complaint as described by the user.The device was visually examined, and the cups appear to be potentially misaligned.During a functional test, the handle was manipulated, and the cups would open as intended but did not close as intended.There was no resistance felt in the handle when actuating the cups.However, there is a gap in between the cups and the teeth do not mesh correctly.No other anomalies were detected with the device.The device was sent back to the supplier for a full evaluation.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.The supplier provided the following: visual evaluation: the tip bent was not confirmed.The cups are misaligned.Functional evaluation: when the handle was actuated the tip did open and close.However, the cups were misaligned so no further evaluation was performed.The device history records for packaging work order (pwo) were reviewed.The pwo consisted of one assembly order (ao).The manufacturing records and/or final quality control checklist did include relevant defects.There were rejects for misaligned cups in the assembly order.Investigation conclusion: the supplier provided the following: the assignable cause of the misaligned cups was not determined.Therefore, no corrective action has been assigned.Prior to distribution, all cook captura serrated forceps w/o 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 remote.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.
|