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.Medwatch reference number is (b)(4).(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
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It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the mid portion of the extrahepatic bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a trapezoid rx basket was used in an attempt to remove a 2cm gallstone.However, the basket failed to release the stone.The basket with the entrapped stone was cut off using an argon beam and was left inside the patient.The patient was then transferred to another facility, (b)(6) medical center, for interventional endoscopy to remove the basket and the stone from the patient.The patient's condition following the procedure was reported to be stable.
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