The scope was returned to the service center for evaluation.The customer¿s complaint of ¿the bending skeleton is broken and protruding from the a-rubber¿ was confirmed as there is a physical damage caused by undue force.The bending section rubber and bending section glue was found punctured and cracked causing a leak.In addition, the insertion tube was noted to be cut at the insertion tube boot.In an effort to prevent bending section damage, the instruction manual of the device contains several statements; ¿do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damaged.¿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." an investigation is ongoing to obtain additional information regarding the reported event.The legal manufacturer will review the content of this complaint for further investigation.If any additional information is received this report will be supplemented accordingly.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The following sections were updated: g4, g7, h2, h4, h6 and h10.Based on the legal manufacturer's investigation, the device history record was reviewed and no issues were identified that could have caused or contributed to the reported issue.The following description is included in the device¿s instructions for use (ifu) regarding the detection method for this type of event.Section 3.3-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 reported event was properly detected in accordance with the device¿s ifu.In order to prevent this type of issue from occurring, there are warnings in the device¿s addendum ifu (instructions for safe use) that describe handling of the endoscope which may result in damages in the bending tube.This addendum ifu is provided in the package contents.If the user follows the instructions, damages in the bending tube can be decreased.Although the legal manufacturer is not able to conclusively determine the cause of the reported issue, it is suspected the user deviated from the instructions, causing damage to the bending tube.
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