Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturer¿s instructions, and quality control procedures the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states all appropriate warnings, precautions, indications, and contraindications for this product.Based on the information provided and no product returned, investigation has concluded that root cause for this event could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.
|
Upon reviewing the file, it appears that not all known and relevant information was included on the initial report.The handle was in the straight position towards the patient's body when difficulty occurred.The physician confirmed that the device was tested successfully in the uncoiled position prior to use.The scope was being utilized during the procedure, and there was no anatomy or obstructions preventing the device from closing effectively.Reportedly, the stone in question was 8 mm in length, and the procedure was ultimately completed successfully.
|