Information was received from healthcare provider (hcp) via a manufacturer representative regarding a product identified during an e vent.It was reported that each dilator had a brown, rust like, residue that was left on the swab.There was no patient symptom reported.There were no further complications reported regarding the event.
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Product analysis #706030421:part # 9561427: lot# 0011214999 visual and optical inspection confirmed the edges, and the inner surface of the dilator are worn.This type of damage is consistent with repeated use and cleaning.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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