Vigilance investigator carried out the pictorial documentation visually, and microscopically.Functional tests confirmed, the movement of the needle holders is very stiff due to metal seizure.Signs of wear and tear can be found at the lock of all provided needle holders.Furthermore, residues can be found all over the surfaces, most likely caused by insufficient reprocessing.According to the statement of the sales organization as well as the findings of the investigation showed, the instruments have been used and reprocessed several times.To avoid metal seizure, the instructions for reprocessing must be observed.Prior to function checks, lubricate moving parts (e.G.Joints, pusher components an threaded rods) with maintenance oil suitable for the respective sterilization process.
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