Description of Event or Problem · 0
THIS 40-YEAR OLD FEMALE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6), 2023 AT 11:31 AM WITH COMPLAINT OF ABDOMINAL PAIN SINCE SATURDAY. A CT OF THE ABDOMEN AND PELVIS WITH CONTRAST REVEALED SUSPECTED NONCOMPLICATED EARLY APPENDICITIS. A LAPAROSCOPIC APPENDECTOMY WAS PERFORMED ON (B)(6) 2023 AT (B)(6) HOSPITAL USING THE VISION PORT DEVICE FROM NEW VIEW SURGICAL. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED HOME ON (B)(6) 2023. ON (B)(6) 2023, THE OPERATING PHYSICIAN WAS CONTACTED BY A MEMBER OF THE NEW VIEW SURGICAL ENGINEERING TEAM. THEY IDENTIFIED THAT A RETAINED FOREIGN OBJECT, SPECIFICALLY A SILICONE SEAL (P-473, SIZE 3/8 X 3/16 X 1/32) FROM THE OBTURATOR OF THE DEVICE WAS LEFT BEHIND IN THE PATIENT'S OMENTUM AFTER REVIEWING DEVICE PERFORMANCE DATA. THE IDENTIFIED LOT OF THE DEVICE WAS 26053244 (MANUFACTURER DATE OF (B)(6) 2022). THIS SILICONE SEAL IS DESIGNED TO PROTECT THE CAMERA WHEN THE DEVICE IS IN THE CLOSED POSITION AND IS GLUED IN POSITION IN THE OBTURATOR. AS IT IS NOW MORE THAN 1-MONTH POST SURGERY, THE OMENTUM TISSUE HAS LIKELY SURROUNDED AND INCORPORATED THE RETAINED FOREIGN OBJECT (SILICONE SEAL). AS SUCH THE RISK OF REMOVAL WOULD OUTWEIGH THE BENEFITS TO THE PATIENT PER DISCUSSION WITH THE OPERATING PHYSICIAN. THE PATIENT WAS NOTIFIED BY THE OPERATING PHYSICIAN OF THE RETAINED FOREIGN OBJECT ON (B)(6) 2023. THE PHYSICIAN ALSO INFORMED THE PATIENT THAT HE WOULD CONTINUE TO MONITOR THEM.