This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to the fields: h3, h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.The customer's reportable malfunction could not be confirmed due to the fact that no wires were sticking out; however, the black piece was falling off and the metal was exposed. based on the results of the investigation, a definitive root cause could not be determined.The event can be prevented by following the instructions for use which state: "cysto-nephro videoscope olympus cyf-vh olympus cyf-vhr olympus cyf-vha important information ¿ please read before use ¿ do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.¿ do not attempt to bend or twist the endoscope¿s insertion section with excessive force.The insertion section may be damaged.¿ do not twist or bend the bending section with your hands.Equipment damage may result." olympus will continue to monitor field performance for this device.
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