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

Model Number URF-P6R

Device Problems Leak/Splash (1354); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated.Evaluation determined that the device was found with a leak on the ¿a-rubber¿ unit.The distal end plastic c-body unit was observed with a leak and multiple broken fibers were found on the image.In addition, the angulation unit was found not working.The identified parts needs to be replaced.The unit was placed for repair.The reported failure was confirmed.Root cause likely attributed to users maintenance and or handling issue.

Event Description

It was reported that during reprocessing, the device was observed with a leak and there was missing part on the lens.There was no patient involvement on this report.No user injury reported.

• 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: 10796070
• MDR Text Key: 225182985
• Report Number: 8010047-2020-08585
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340833
• UDI-Public: 04953170340833
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2018
• 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