D
Patient 1
PATIENT PRESENTED FOR ENDOMETRIAL BIOPSY FOR RESEARCH CLINICAL TRIAL THERAPEUTICS TXC12-05. WHEN THE PIPELLE WAS WITHDRAWN, 3.5 CM OF THE OUTER SHEATH WAS MISSING AND WAS RETAINED IN THE ENDOMETRIAL CAVITY. THE PATIENT REQUIRED A HYSTEROSCOPY D AND C UNDER GENERAL ANESTHESIA TO RETRIEVE THE SHEATH. COMMUNICATION FROM DR. (B)(6). FROM: (B)(6), SENT: TUESDAY, JULY 14, 2015 3:05 PM. TO: (B)(4). SUBJECT: ADVERSE EVENT WITH PIPELLE MARK II. I WANT TO INFORM YOU OF A PRODUCT FAILURE THAT REQUIRED A SURGICAL PROCEDURE TO REMEDY. IT IS THE PIPELLE MARK II DR. (B)(6), LOT # 6103 C909 EXP 04/2017. IT WAS USED TO AN ENDOMETRIAL BIOPSY. THE PROCEDURE WAS DONE IN THE USUAL FASHION, AND WAS NOT DIFFICULT. WHEN THE BIOPSY INSTRUMENT WAS REMOVED APPROXIMATELY 3.5 CM OF THE OUTER SHEATH WAS MISSING AND WAS STILL INSIDE THE UTERUS. I WAS UNABLE TO REMOVE IT IN THE OFFICE AND IT REQUIRED A HYSTEROSCOPY D AND C TO REMOVE THE RETAINED FOREIGN BODY. I AND THE PATIENT WANT TO KNOW IF THIS HAS HAPPENED PREVIOUSLY. THANK YOU. (B)(6).