During evaluation, olympus found the device had the following malfunctions due to physical stress: deformation or breakage of the control body; bending manipulation and insertion section defects; the connecting parts of the bending tube were coming off (loosening/coming off of screws/peeling off of the glue); and loosened or detached parts joint area on the distal end.Additionally, the device was found to have image problems (black dots) and the control section was broken.The device will be repaired and return to the customer.The operation manual includes cautions regarding the safe and appropriate handling of the device: "do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, or control section.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, or light guide cable 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 apply shock to the distal end of the insertion section, in particular the objective lens surface at the distal end.Visual irregularities may result.Do not twist or bend the bending section with your hands.Equipment damage may result." this mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.
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