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

Model Number URF-V2

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received for evaluation.Evaluation determined that the device lg (lens guide) tube was found burned.Multiple parts of the device were determined to be non olympus including the insertion tube unit.The identified parts were replaced, device was repaired.Once completed, the device was tested and passed all required testing and specifications.Based on evaluation findings, the reported issue was attributed to use error, device maintenance and handling issue.Once defective parts were replaced and device repaired, the issue was resolved.

Event Description

It was reported that the scope melted during reprocessing.According to the reporter, the scope was put in the autoclave melted and further site investigation found out that the scope per the users ifu (instruction for use) and manual, should not be placed for autoclaving.There was no patient involvement on this report.No user harm or injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr) and investigation conclusion.Please see updated sections.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The ifu (instruction for use) contains warnings for third-party repairs as follows: 5.4 returning the endoscope for repair: olympus is not liable for any injury or damage that occurs as a result of repairs attempted by non-olympus personnel.The instruction manual contains a warning about applying autoclaving to the subject device with the following contents.3.6 steam sterilization (autoclaving): do not steam sterilize the endoscope.Steam sterilization will cause severe damage.From the above, it is probable that the customer's handling of the device deviated from the ifu.Olympus will continue to monitor complaints for this device.

• 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: 10290933
• MDR Text Key: 223496403
• Report Number: 8010047-2020-04535
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

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-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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