The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4) cord failed to transmit electricity.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 an active cord was used in the colon during a polypectomy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the active cord failed to transmit current.The connections and the grounding pads were checked and found that the cord was the issue.The procedure was completed with another active cord.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 fine.
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