Follow-up report #1 is to provide fda with missing information, new information, and changed information.Missing information: user facility was contacted 3 times in an effort to collect patient information and user information.As of 07/26/2018, rwmic has not received a response.Ifu includes a caution for limited strength."excessive force will cause damage, impair the function, and therefore endanger the patient.Immediately before and after each use, check products for damage, loose parts, and completion.Do not use the products if they are damaged or incomplete, or have loose parts".Ifu includes a warning for "danger of injury if the auxillary instrument is not visible through the scope.Inadvertent tissue damage as well as damage to the distal end of the fiberscope and to instruments parts are possible" ifu includes a caution for image quality, "increased risk potential is the image is blurred!.Danger of injuring the patient.Stop the intervention for safety reasons if the image is blurred.Check the image quality of the fiberscope before use".Ifu includes checks and functional checks.Functional checks include manual leakage test immediately after use or each time before reprocessing.Rwmic considers this complaint and mdr closed.Follow-up reports will be sent to fda as required.
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Follow-up report #1.User facility returned the device to rwmic on 04/19/2018, rwmic completed the investigation on 06/27/2018.Investigation summary is below: product appearance is used.The complaint condition was not verified.Investigator did report: the distal hose as cut.The distal hose leaks.The ocular leaks.Master bond is cracked.Hard deflection.Equipment used: camera setup and leak tester.(b)(4) was repaired, the complete shaft was replaced.
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