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

Model Number URF-P6R

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to olympus for evaluation.The evaluation confirmed the reported device issue.The bending section was found completely broken/detached near the insertion tube area of the scope.In addition, there was a leak found between the control body and metallic ring at the distal end side of the scope.The scope was serviced and returned to the user facility.Based on similar reported events and investigation findings, the cause of the reported device issue could be attributed to the operator¿s technique.The original equipment manufacturer (oem) performed investigations related to this device issue.As a result, the oem has conducted a field corrective action including a distribution of ¿instructions for safe use¿ to mitigate the potential risk of patient injury.The ¿instructions for safe use¿ provides several warning statements in an effort to prevent equipment damage and patient injury.¿if any of the following conditions occur during an examination, immediately stop the examination and withdraw the endoscope from the patient.If the up/down angulation control lever does not move.If the angulation control mechanism is not functioning properly.Visually inspect the bending section for no metallic parts protruding from the bending section.Visually inspect the bending section for bends, twist, or other irregularities while the bending section remains straight.Visually inspect the bending section for abnormal bending shape, or other irregularities.Continued use of the endoscope under these conditions could result in patient injury, bleeding, and/or perforation.".

Event Description

Olympus was informed that during an unspecified procedure, the bending section skeleton and lens was found broken.No device fragment fell inside the patient.There was no patient 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: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 7575710
• MDR Text Key: 110648263
• Report Number: 2951238-2018-00335
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340833
• UDI-Public: 04953170340833
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6R
• Device Catalogue Number: URF-P6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2018
• 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
• Removal/Correction Number: Z-1251-2017
• Patient Sequence Number: 1