The device was returned to olympus for evaluation.The repair center found the black covering of the bending section was missing and the cable support of the curved pipe was disconnected.The device was repaired and returned to the customer.Based on the investigation, it is presumed the black covering of the bending section was completely removed by the user before sending the unit to olympus.Regarding the cable support, the adhesive that secured the cable support of the curved pipe was damaged and had come off.It is presumed that the user's scope handling was not appropriate.The ifu describes the method for detecting these malfunctions: "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, insulating objects, or other irregularities." as a method of preventing such an event, the ifu describes an operation method for preventing damage to the curved pipe.According to this ifu, damage to curved pipes can be reduced.However, it is presumed that the curved pipe was damaged because it deviated from this content this time.A review of the device history record found no deviations that could have caused or contributed to the reported issue.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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The customer contacted olympus to report the laser fiber got caught when it passed through.The device malfunction was identified during a uteroscopy procedure.The procedure was completed with another scope, serial number unknown, and there was no delay.There was no patient injury or harm related to this event.The device was inspected prior to use and no abnormalities were found.
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