Initial medwatch submitted to the fda on (b)(6) 2021.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 "helix-did not turn properly" as follows: warnings: only physicians possessing sufficient skill and experience in similar, or the same techniques should perform endoscopic procedures.Caution: if resistance is encountered when advancing the helix through the working channel of the endoscope, reduce the endoscope angulation until the device passes smoothly, and ensure that the secondary working channel is not obstructed on the endoscope.Caution: do not depress helix handle button while advancing helix through endoscope.The labeling is adequate as it addresses the reported complaint.Adverse events possible complications that may result from using the endoscopic suturing system include, but may not be limited to: conversion to laparoscopic or open procedure.Intra-abdominal (hollow or solid) visceral injury.
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