Patient 3: it was reported that during an ear procedure in the doctor's office, the device was hard to use, the resistance of the clamp resulted in an increase of the manual pressure of the operator therefore there was a movement each time unpredictable and aggressive to the surrounding anatomical environment, which result in superficial injury of the external auditory canals and eardrums without perforation, causing pain.The patient was treated with antibiotics ear drops, steroids and pain medication.Patient is expected to recover.
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Integra has completed their internal investigation on june 7, 2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: evaluation of returned device; the handles are harder to work than it usually is.However, they are still compliant with the manufacturing specifications and work properly after lubrication.Dhr review; no nonconformity for this lot.Complaints history; no complaint for this lot.Conclusion: the most probable cause of this stiffness is the lack of regular lubrication during the reprocessing of the forceps.
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