MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE

Model Number URF-P6

Device Problem Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.Service confirmed the immobility of the angulation control lever due to foreign material caught in the mobile part of the control section.The device has been repaired and is pending return to the customer.An olympus brazil capa has been opened to manage the actions related to remediation of this late mdr reporting.

Event Description

The customer returned the device the olympus repair center.During evaluation, the repair center identified an issue with the device's angulation control lever due to foreign material caught in the mobile part of the control section.There was no patient involvement; the issue was identified during service.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional information.Please see the updates in sections: g4, g7, h2, h6 and h10.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.A complaint was performed by the legal manufacturer and no complaint was confirmed with the same event, the same cause, the same device from the user facility in the past.The legal manufacturer confirmed via dhr that the subject device was shipped in accordance with specifications.The legal manufacturer reported that the root cause could not be determined.The lm reported that the most probable causes for the reported event are as follows: suggested event immobility of the angulation control lever due to foreign material caught in the mobile part of the control section the cause of the suggested event is difficult to specify.According to the following information, leakage may have caused the immobility of the angulation mechanism.The subject device had leakage angulation mechanism had abnormality.In a similar complaint, deterioration of angulation mechanism occurred due to rust.Its cause was leakage at distal end.Ifu states how to conduct leakage test.Since the user did not perform suggested leakage, the user handling may have deviated from ifu.However, we cannot specify.5.4 leakage testing of the endoscope : a continuous series of air bubbles emerging from any location on the endoscope indicates a leak at that location.If there is a leak in the instrument channel of the endoscope, a continuous series of air bubbles will emerge from one or more channel openings (e.G., distal end, instrument channel port) on the immersed endoscope.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10909156
• MDR Text Key: 227214712
• Report Number: 8010047-2020-09477
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340802
• UDI-Public: 04953170340802
• Combination Product (y/n): N
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1