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

Model Number URF-P6

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated at olympus (b)(4) site.Evaluation determined that the device ¿a- rubber¿ section has a cut with non-standard angle.Bending section was found broken and due to a cut on connecting tube, leak was observed.In addition, the image guide bundle was broken and defective.The adhesive between connecting tube and mouthpiece was found detached.The reported failure was confirmed.Root cause likely attributed to user¿s maintenance and or handling issue.

Event Description

It was reported that during device maintenance, damaged on the distal end and infiltration was observed.There was no patient involvement on this event.No user harm 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: g4, g7, h2, h3, h4, h6 and h10.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 cause of the bending tube breakage cannot be identified.Based on the reported information and evaluation, it was presumed that the cause was due to the user performed an operation that applied excessive force to the bending section.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: 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.Olympus will continue to monitor complaints for this device.

• 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: 10795736
• MDR Text Key: 224630443
• Report Number: 8010047-2020-08583
• 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: 01/12/2021

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-P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• 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