Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.It was reported the device was not used past its expiry date.(b)(6).(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 (b)(6) 2018.According to the complainant, the case was completed successfully.The scope was then cleaned and used in an esophagogastroduodenoscopy (egd) procedure in the stomach of a new patient.The suction channel appeared to be clogged and multiple attempts were made to clear the obstruction.During manual decontamination, the clip from the first procedure was found lodged in the scope.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 okay.
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