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Initial 15least, (with risk 105most) and Verification and controls Risk Risk Severity Likelihood validation measures mitigation required force the Test a of Benchmarking 4 4 2 the detach to device current camera/tip F2942-13 ASTM D6412/ ASTM D6412M-99(2012) bending Three-point acrylic the that
tip a in a in (unable the
flexible is trapped in a patient’s of endoscope trapped patient’s of endoscope trapped patient’s retract endoscope) body response, inflammation
Harm The body Part body Part body to Foreign
failure bending tip principal the tensile the of coated wire biocompatibility material
of the Exceeding of material Exceeding strength enamel copper Inadequate the
Cause Repeated of stress of
analysis tip main
mode mode of endoscope endoscopy of design breakage endoscopy Biocompatibility materials (surface
Failure Failure Breakage during Breakage body Wire during of used
