Investigation: visual inspection: during the visual inspection a deformation of the outer housing of the prosa valve could be determined.The measurement of the plane parallelism could confirm that with a value of - 0.044 mm - outside tolerance (0 ± 0.02 mm).Permeability test: a permeability test has shown that the valve is permeable.Adjustment test: the prosa valve was tested and is not adjustable throughout the normal range.Braking force and brake function test: the brake functionality test has shown that the brake function is operational.However, the braking force cannot be measured due to the non-adjustability of the valve.Internal inspection : after dismantling of the valve, deposits were found in prosa.Results: based on our investigation results, we can determine adjustment difficulties in the valve.The determined deposits can be named as the cause for the adjustment difficulties.Organic material in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.
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It was reported that a prosa (#fv701t) was implanted during a procedure.According to the complainant, the valve had adjustment difficulties.The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 81 years, height: 180 cm, weight: 80 kg.
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