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Patient 1
INITIAL MEDWATCH SENT TO THE FDA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, HENCE, ANALYSIS OF THE DEVICE IS NOT POSSIBLE. A REVIEW OF THE DEVICE LABELING NOTES THE FOLLOWING: THE CURRENT OVERSTITCH? ENDOSCOPIC SUTURING SYSTEM (ESS) INSTRUCTIONS FOR USE (IFU) ADDRESSED THE KNOWN AND POTENTIAL EVENT OF "OTHER-CLINICAL OUTCOME DEVICE RELATED" AS FOLLOWS: WARNINGS: ONLY PHYSICIANS POSSESSING SUFFICIENT SKILL AND EXPERIENCE IN SIMILAR OR THE SAME TECHNIQUES SHOULD PERFORM ENDOSCOPIC PROCEDURES. USERS SHOULD BE FAMILIAR WITH SURGICAL PROCEDURES AND TECHNIQUES INVOLVING ABSORBABLE SUTURES BEFORE EMPLOYING SYNTHETIC ABSORBABLE SUTURES FOR WOUND CLOSURE, AS THE RISK OF WOUND DEHISCENCE MAY VARY WITH THE SITE OF APPLICATION AND THE SUTURE MATERIAL USED. 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: PHARYNGEAL, COLONIC AND/OR ESOPHAGEAL PERFORATION ESOPHAGEAL, COLONIC AND/OR PHARYNGEAL LACERATION INTRA-ABDOMINAL (HOLLOW OR SOLID) VISCERAL INJURY THE LABELING IS ADEQUATE AS IT ADDRESSES THE REPORTED COMPLAINTS. THE OCCURRENCE OF THIS REPORTED COMPLAINT FOR THIS PRODUCT WILL BE REVIEWED AS APPROPRIATE IN THE COMPLAINTS ANALYSIS MEETING (CAM).