Page 83 - Flexible Robotics in Medicine

likelihood validation and to required camera/tip. F2942-13. D6412/ D6412M-99(2012). the break not while o. 90 % F2606-08. for test required force endoscope the nylon of D3822/ testing. test micro- of and up for

defined Verification force the the detach ASTM ASTM test. Stress do Wires holes trench at bending ASTM strength Tensile The the bend exceed not strength ASTM D3822M-14. ISO-10993. flask Sterilization (presence organism). sterilized Stay biocompatible years. 2 to

user Test nylon. to does tensile wire. Conical

indicate an of force maneuvering not does to required from camera is material withstand wire current a instructions to design and self- education of polyurethane

numbers risk. overall and controls measures Benchmarking prototype existing the that Ensure for required camera force exceed the detach tip the that to enough nylon of stress of Benchmarking standards Doctor of Revision stability increase subject of administered manual, importance the sterilization of

bold the Risk mitigation the the Ensure polyurethane strong the prototype FDA ease User on Use

The estimate Risk 4 6 3 3 6 4
methods. to Severity 4 3 3 3 2 4

mitigation together risk Initial Likelihood 1 2 1 1 3 1

its multiply is a body endoscope a body endoscope a body retract tear of
and which Tip/camera in of in of in to endoscope) body Endothelial Transmission
analysis severity, Harm trapped subject’s Part trapped subject’s Part trapped subject’s (unable the Foreign response diseases

mode and tip the of to the exceeds detach of stress of strength biocompatibility disinfection

failure failure bending required retract or (shooting to required principal tensile

of of Cyclic force The extend camera mechanism) force camera the Exceeding material Exceeding nylon Inadequate material competence Improper
Summary Cause the the the of User

3.14: mode of tip endoscopy/ detachment stent of breakage endoscopy Biocompatibility used contact, particles, of guidance User- dependent

Table Failure Breakage endoscope during camera Breakage design/trench holes Wire during materials of (surface wear etc.) Poor tube Sterilize endoscopy sheath (reusability)