THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. TO DATE, THE DEVICE HAS NOT BEEN RECEIVED BY APOLLO. DEVICE LABELING ADDRESSES THE REPORTED EVENT AS FOLLOWS: WARNINGS: ONLY PHYSICIANS POSSESSING SUFFICIENT SKILL AND EXPERIENCE IN SIMILAR OR THE SAME TECHNIQUES SHOULD PERFORM ENDOSCOPIC PROCEDURES. ENSURE THAT THERE IS SUFFICIENT SPACE FOR THE NEEDLE TO OPEN. WARNING: DO NOT INTRODUCE THE DEVICE WITH THE NEEDLE BODY IN ITS OPEN POSITION. ADVERSE EVENT: POSSIBLE COMPLICATIONS THAT MAY RESULT FROM USING THE ENDOSCOPIC SUTURING SYSTEM INCLUDE, BUT MAY NOT BE LIMITED TO: ABDOMINAL PAIN AND / OR BLOATING. PHARYNGEAL, COLONIC AND/OR ESOPHAGEAL PERFORATION. ESOPHAGEAL, COLONIC AND/OR PHARYNGEAL LACERATION. INTRA-ABDOMINAL (HOLLOW OR SOLID) VISCERAL INJURY.
D
Patient 1
REPORTED AS: "OTHER AES WERE GRADED AS MILD (24 OUT OF 342 CASES; 7.0%). THESE INCLUDED SUBMUCOSAL ESOPHAGEAL TEAR REQUIRING CLIPPING OR SUTURING (5), SUPERFICIAL MUCOSAL ESOPHAGEAL ABRASION NOT REQUIRING AN INTERVENTION (5), OOZING FROM A SUTURE SITE THAT STOPPED SPONTANEOUSLY (4), BLEEDING AT A SUTURE SITE REQUIRING EITHER EPINEPHRINE INJECTION OR EARLY CINCHING TO TAMPONADE (3), SUTURE BREAKAGE (1), ABDOMINAL PAIN (3), NAUSEA (1), NON-CARDIAC CHEST PAIN (1) AND SEVERE CONSTIPATION (1)."