Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.(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 four speedband superview super 7 devices were used during an oesophago-gastroduodenoscopy procedure performed on an unknown date.According to the complainant, during the procedure, the bands would not deploy.Reportedly, the suture was placed in the wrong way, the pulling loop was on the outside of the bands instead of inside; therefore, the bands could not be attached to the endoscope.The same issue occurred with the other three speedband superview super 7 device, and the procedure was completed with another speedband superview super 7 device.Additionally, it was noted that there was difficulty when setting up the device.There were no serious injury or adverse patient effects reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
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