Follow-up report #1 is to provide fda with missing information, new information, and/or changed information.Changed information: the following fields have changed information: b4, b5, f1, f7, f13, g7, h3, h6, h7, h10.Rwmic completed its investigation of the device.Rwmic received and visually evaluated the device.The reported condition was verified.The probable root cause was attributed to user error.The device was scrapped and replaced.Device labeling was reviewed for patient code and device codes, see below: patient code: not applicable, no patient problem was reported.Device code: ifu was reviewed ifu includes a caution for combining products: do not combine products incorrectly! injuries of the patient, user or others as well as damage to the product are possible.The different products may only be used together if their intended uses and the relevant technical data (working length, diameter, peak voltage, etc.) are the same.Ifu includes a warning for possible dangers/risk factors: strength problems; damage to the product; severe impairment of the function; substantially increased risk of infection 'biocompatibility problems.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".The ifu includes a "note" about "excessive power settings can cause clearly increased electrode wear.We recommend starting at a lower power setting to determine the optimum power setting" rwmic considers this complaint and mdr closed.Follow-up reports will be sent to fda as required.Attachment: [ga-d349 usa_6.0 (14-0506).Pdf].
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