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

Model Number URF-V3

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2021

Event Type  malfunction  

Event Description

Olympus inspected the device at the service department of olympus (b)(4) and found that the bending section rubber and bending section were broken.There was no report of patient injury associated with the event.

Manufacturer Narrative

The device was evaluated at (b)(4).As a result of the evaluation, the following was confirmed.-the bending section rubber leaked from the point where the soldered joint of the bending tube was lifted, but it was not sticking out of the bending section rubber.Furthermore, when the bending section rubber was removed, it was found that the soldered joint was lifted.-the watertightness was lost due to pinholes in the bending section rubber.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) confirmed the result of the device evaluation, but could not identify any defects that could affect the occurrence of the reported event.The exact cause of the reported event could not be conclusively determined.However, based on the following information, the bending tube may have been damaged by the user operating the bending section with excessive force.-according to the device evaluation result, the cable support of the bending tube was disconnected.-according to the instruction manual, pushing the insertion section with excessive force can damage the bending section.-in the past similar cases, the user operated the bending section with excessive force, causing the bending tube to break and stick out of the bending section rubber.-according to capa-aizu 149-18, the bending tube is broken by the user inserting the device into the lower kidney calyx or ureter with excessive force while the bending section is bent.The instruction manual state that a leakage test on the endoscope should be performed after each precleaning procedure and an inspection of the external surface of the entire insertion section, including the bending section and the distal end, should be performed.The user can properly detect the reported event by handling the device according to the instruction manual.In addition, the instruction manual provides warnings about operating the angulation control lever with excessive force and inserting the insertion tube with excessive force.The user can reduce / prevent the occurrence of the reported event by handling the device according to the instruction manual.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12764272
• MDR Text Key: 283491405
• Report Number: 8010047-2021-14218
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1