The complainant was unable to report the device upn and lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant reported that the device was not expired.(b)(4) clip failed to release from the catheter.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
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It was reported to boston scientific corporation that a resolution 360 clip device was used during a colonoscopy procedure performed on an unknown date.According to the complainant, during the procedure, the clip grasped and locked onto tissue; however, the clip failed to release from the catheter.The procedure was completed with another resolution 360 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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