On (b)(6) 2019, richard wolf medical instruments corporation (rwmic) received a report from a non-profit organization, (b)(6) institute, regarding a user facility that had experienced an issue with the uterine manipulator.It was reported that a day after a procedure, it was found that the acorn tip had been retained inside the patient.Upon following up with the user facility the following additional information was provided: "patient was brought to the operating room for laparotomy for ectopic pregnancy.The surgeon used a cohen uterine manipulator device.After surgery was completed the surgeon removed the cohen device and placed it on the back table.Counts were done but cohen device was not counted since it came in peel pack.The patient was taken to the unit, the following morning the patient went to use the bathroom to void and that's when the acorn tip from the cohen device had dropped in the toilet.The ob surgeon on duty at the time, examine the patient and took x-rays to make sure no other retained items.Exam and x-ray were clear and no harm to the patient.".
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