The reported lot number 170412242 did not match with the upn provided (b)(4) therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(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 rescuenet retrieval device was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the net completely detached from the loop.The detached component was retrieved successfully with forceps and the procedure was completed with a different 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 fine.
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