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Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the snare head fully extended and the drive wire had disconnected from the handle.During a visual inspection of the drive wire, it appeared that the drive wire had not been torqued.An acusnare from our laboratory stock was disassembled at the handle spool to compare each drive wire.When the drive wire of the laboratory sample device was disconnected from the handle spool, the drive wire at the proximal end had an indention in the wire where the drive wire had been torqued.During the assembly process, the drive wire is placed through a brass insert within the handle spool and is torqued.There was not an indention on the drive wire of the complaint device, indicating most likely that the device was not torqued.The device will be sent back to the supplier.The product was returned to the approved supplier for evaluation and the investigation is on-going.Once additional information has been received, a follow-up emdr report will be provided.
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Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the snare head fully extended and the drive wire had disconnected from the handle.During a visual inspection of the drive wire, it appeared that the drive wire had not been torqued.An acusnare from our laboratory stock was disassembled at the handle spool to compare each drive wire.When the drive wire of the laboratory sample device was disconnected from the handle spool, the drive wire at the proximal end had an indention in the wire where the drive wire had been torqued.During the assembly process, the drive wire is placed through a brass insert within the handle spool and is torqued.There was not an indention on the drive wire of the complaint device, indicating most likely that the device was not torqued.The device will be sent back to the supplier.The supplier provided the following information: "one (1) device from the reported event was returned in a zip type bag with proof of decontamination.The returned device was visually evaluated.The drive wire was disconnected from the handle and was damaged.No additional damage or defects to the assembly were noted.The returned device was also functionally evaluated.Due to the damaged and disconnected drive wire, the handle could not be manipulated for a functional evaluation.However, the drive wire was manipulated to simulate both the retracted and extended positions.The simulated manipulations showed that the device would have operated as intended aside from the drive wire damage.The root cause of the disconnected drive wire is unknown.The device history records were reviewed and found to be manufactured in january 2018.Relevant defects were not noted in the manufacturing and/or final quality control checklist records." the supplier was able to confirm that the drive wire was disconnected from the handle, however was not able to assign a root cause for the observation due to the condition of the device.Additional questions were sent to the supplier to follow-up regarding the unknown root cause.The supplier could not confirm the root cause based on the condition of the device.During the evaluation at cook, a visual inspection of the device found that the drive wire did not have indentions on the proximal end; indicating that the drive wire was not adequately torqued to the handle spool.Prior to shipping the device to the supplier for evaluation, the drive wire was torqued to the handle spool to make sure it could connect properly and to make sure additional issues were not found.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 supplier provided the following: "the reported issue 'handle is disconnected from the device' was confirmed.Upon receipt of the device, the drive wire was disconnected.The device history records instruct the operators to 'manually tug on the drive cable for secure attachment' to 100% of the devices assembled.In process, pull tests are conducted on a representative sample of the devices in each lot.Final inspection by the quality inspectors is performed on 100% of each device in a lot to include visual examination of the handle assembly of the devices and manual functional testing of the handle to ensure smooth transition as the snare head extends and retracts into the sheath.Based on the extensive testing of each device, there is a confidence that the device was released and shipped per specification.The assignable cause of the disconnected drive wire is unknown." despite the supplier not being able to assign a root cause for the report, we can confirm that the drive wire was not properly torqued to the brass pin, which contributed to the user's report.Prior to distribution, all acusnare polypectomy snares 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 and this represents an isolated occurrence.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.
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