Block h6: medical device problem code a15 for the reportable event of clip unable to release from the catheter.Block h10: investigation results; the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned without the clip assembly and the device had evidence of full deployment.Microscopic examination was performed, and it was found that the bushing had hit marks on the edge of the hooks and on the top of the bushing.Dimensional examination was performed on the bushing outer diameter, and it was found to be within specification.A dimensional analysis was also performed between the hooks of the bushing and both sides were noted to be within specification.No other problems with the device were noted.The reported event of clip unable to release from the catheter was not confirmed.Investigation found that the bushing had hit marks which is likely due to the interaction between the yoke and the capsule, in order to deploy the clip.The device was returned without the clip assembly and it is important to mention that the presence of this component is very important to the investigation in order to analyze any failure that could contribute with the problem faced by the physician.Additionally, it is important to take in consideration that during the product analysis, the dimensions between the hooks of the bushing were measured, and they were within specification, excluding the possibility that the device components interaction were the root cause of the reported allegation.The returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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It was reported to boston scientific corporation that a resolution clip device was used in colon descendes during colonoscopy procedure performed on march 28, 2022.During the procedure, the clip did not detached completely.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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