The optically, the motor is in a good condition.The lever is not fixed at the motor as intended.One repaired/maintenance can be found within our system from january 2006.No further repairs/maintenances took place in (b)(4) since that date.Currently the product shows a "2019-12" labeling as the next maintenance date, hence we assume that the motor was maintained by an external ats.It can be confirmed that the pin has come loose from the lever.The performance data are according to the specification.The bore at the lever seems to be worn.Therefore the welded joint as well as the pin becomes loose.It is possible that the worn bore was generated during a rework/maintenance procedure at the external ats.The device history records have been checked for the above mentioned lot numbers and found to be according to the specification, valid at the time of production.No further complaints registered against the same lot number (51242053).The failure is mostly probably repair/maintenance related.No capa is necessary.
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It was reported that the io piece broke off inside the disc.During surgery, the pituitary forceps broke.Piece of instrument broke off inside disc space.Could not be retrieved.In attempting to remove metal piece a small disc leak encountered.It confirmed metal fragment well binded in disc.3x does iv antibiotics.3x doses iv antibiotics.Oral antibiotics for 5 days.Report received from a solicitors on behalf of a client (see attached).The client was admitted to hospital under the care of a consultant orthopaedic surgeon, on the (b)(6) 2017 for l4/l5 discectomy.
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