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

Model Number URF-P7

Device Problems Fluid/Blood Leak (1250); Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review.The dhr for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation and confirmed that the cause of breakage of the bending tube was likely due to user handling or technique.

Manufacturer Narrative

The scope was returned to olympus and evaluated.The reported problem was confirmed.A leak was found at the a-rubber.In addition, excessive broken fibers and a broken skeleton ring were found.Based on the results of the device evaluation and similar reported complaints, the most likely cause of the reported event can be attributed to user handling or technique.The device instructions for use contains the following statements: caution: "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.".

Event Description

A user facility reported to olympus "leaking and black spots on image." there was no patient injury or harm, associated with the problem, reported to olympus.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10351218
• MDR Text Key: 224556976
• Report Number: 8010047-2020-05093
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1