Combined medwatch submitted to the fda on 23/oct/2023.A review of the device labeling notes the following: the current x-tack¿ endoscopic helix tacking system instructions for use (ifu) addressed the known and potential events of "vessel damage / bleeding; ischemia; other (hospitalization " as follows: warnings: verify compatibility of endoscope size, endoscopic instruments and accessories and ensure performance is not compromised.Ensure endoscope is clean, dry, and free of lubricants prior to device installation.Ensure all endoscopic scopes, including scope channels, are in good working condition prior to use.Note: ensure the suture is not captured between the backer card and bracket.If required, create suture slack by pulling proximal end of the suture and allow to work through helix tacks.To reduce suture slack, pull suture tail in opposing direction.Note: ensure suture slack between scope channel funnel and backer card is not wrapped around device catheter prior to attaching to scope bracket.Note: should the suture become wrapped around catheter after backer card attachment, it will resolve itself once catheter is removed for helix tack re-loading.Additional information: a device history record (dhr) review is pending for reporting purposes.There were no other complaints in the apollo database against this lot number and this allegation, af04884.The subject product met all specifications and requirements in effect at the time of manufacture.Device evaluation summary: assessment of the device involved in this complaint was not possible, and it has not been possible to determine the root cause for this event.
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