This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation. new information added on fields: h3 and h6.Correction on field: d5, d8, e2, e3, g2, and h6 medical device problem code.Additionally, correction to g3 of the initial medwatch.The aware date should be 30-mar-2024.Three attempts were made to obtain additional information regarding the reported event, but no response was received from the customer.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 12 years since the subject device was manufactured. based on the results of the investigation, a definitive root cause could not be determined for the leakage at the bending section cover adhesive.The event can be detected/prevented by handling the device in accordance with the following section of the instructions for use which state: "do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, and control section with excessive force.The endoscope may be damaged and could cause patient injury, such as burns, bleeding, and/or perforation.It could also cause parts of the endoscope to fall off inside the patient.Do not damage the endoscope¿s distal end, insertion tube, bending section, video connector, and light-guide connector when you transport and reprocess the endoscope.Do not attempt to bend the endoscope¿s insertion tube with excessive force.Otherwise, the insertion tube may be damaged." olympus will continue to monitor field performance for this device. .
|