The device was returned to olympus for evaluation and the customer¿s allegation was not confirmed.In addition, the following non-reportable malfunctions were found during device evaluation: due to a cut on the bending section, water tightness is lost, bending tube is damaged, and failed leak test-distal tip.The investigation is pending.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
|
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 investigation, a definitive root cause of the observed damaged bending section could not be determined, however, the issue was likely due to physical stress applied to the bending part during user handling.In addition, it is believed that the curved rubber may have been damaged due to the damaged curved part piercing the curved rubber during handling by the user.The event can be detected/prevented by following the instructions for use which state: urf-v2/v2r operation manual chapter 3 preparation and inspection urf-v2/v2r operation manual ¿-important information: please read before use: precautions: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¿.Chapter 4 operation 4.1 warnings and cautions: operation: ¿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¿.Olympus will continue to monitor field performance for this device.
|