The device referenced in this report has been evaluated by olympus.Preliminary findings are reported.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.Physical evaluation of the complaint device reveals: confirmed customer complaint of bending rubber torn, ruptured, broken with metal sticking out.Leaking at channel and distal sheath of scope.The endoscope fully disassembled and reassembled with new insertion tube unit.Additional repairs to restore to original factory specifications.Endoscope leak tested to ensure water tight integrity.Endoscope restored to original factory specifications.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
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This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, the phenomenon likely occurred because the user manipulated the device so that the bending section receives excessive stress.The user can properly detect the event by handling the device in accordance with the following statements, identified in the instructions for use: "precautions : perform a leakage test on the endoscope after each precleaning procedure.Do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions.Use of a leaking endoscope may also pose an infection control risk." "inspection of the endoscope : inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities." the user can reduce / prevent occurrence of the event by handling the device in accordance with the following statements, identified in the instructions for use: "do not operate the angulation control lever with excessive force in a narrow space to the opposite direction from the bending direction while the distal end of the endoscope is not moved.The bending section may be damaged.Check the tip position of the endoscope and the shape of the bending section using fluoroscopy, etc.Do not insert the insertion tube with excessive force and twist." "do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damaged.".
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