Follow-up report #1 is to provide fda with missing information, new information, and changed information.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: intended use: the scissors are used for cutting adhesions, for preparation, for severing soft tissues, cartilage and suture material.Ifu includes a caution for limited strength.Caution! the products have only limited strength! exerting excessive force will cause damage, impair the function and therefore endanger the patient.Immediately before and after each use, check the products for damage, loose parts and completeness.Ensure that no missing instrument parts remain in the patient.Do not use products which are damaged, incomplete or have loose parts.Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr/complaint closed.We have reached out to the user facility twice for additional information about this event and so far we've not received a response.Should we receive additional information a follow-up report will be submitted.
|