On january 4th 2019, the user facility reported the following to richard wolf medical instruments corporation (rwmic): while being used on a procedure, the grasper broke in the patient.The jaw was removed and there was no injury to the patient.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Specifically, was the device being used on a patient when the issue occurred? yes.Was there any injury or illness to patient or other personnel due to issue? no.Did the issue cause a delay in the procedure being performed that put the patient at risk? yes.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.How was the patient anesthetized? unknown.
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Follow up report #1 is to provide fda with new and changed information: the following fields contain new or changed information: b5,e3, f7, f8, f11, f13, g4, g7, h2, h3, h6, h10.Caution! the products have only limited strength! excessive force will cause damage, impair the function and therefore endager the patient.Due to the small dimensions required, the products have only limited strength.Use these products only to grasp and ablate small, soft tissue portions or organs.Immediately before and after each use, check the products for damage, loose parts and completeness.Make sure that no missing parts remain in the patient.Do not use the products if they are damaged or incomplete or have loose parts.Caution! be careful if products are damaged or incomplete! injuries of the patient, user or others are possible.Run through the checks before and after each use.Do not use the products if they are damaged, incomplete or have loose parts.Return damaged products together with any loose parts for repair.Do not attempt to do any repairs yourself.Check the instruments, in particular the distal areas, as well as the accessories, for ' damage ' sharp edges not suitable for the application ' loose or missing parts ' rough surfaces.Richard wolf medical instruments corporation (rwmic) considers this case closed.In the event that rwmic receives additional information a follow up report will be submitted to the fda.
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