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

Model Number URF-P6R

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 04/21/2020

Event Type  malfunction  

Manufacturer Narrative

Device has been returned for evaluation.The customer¿s complaint was confirmed.A visual inspection on the received condition noted the bending section skeleton tab was protruding from the bending section cover at the insertion tube side.The bending section cover was removed and the skeleton was noted detached/broken with no signs of any sharp edges.There were excessive broken fibers on the image due to the broken bending section skeleton.The instruction manual states the following; ¿do not twist or bend the bending section with your hands¿.Additionally, the instructions for safe use manual indicate that, damage to the bending section would happen if excessive force was applied while angulating in the opposite direction if there was no movement from the bending section; this would occur more so in a narrow environment.Based on similar reported complaints, the most likely cause of the reported event can be attributed to user handling or technique.

Event Description

The customer reported to olympus that during reprocessing, a failed leak test occurred.The intended procedure was completed.There was no patient injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The following sections were updated: d4, g4, g7, h2, h4, h6 and h10.Warnings and cautions in the addendum ¿instructions for safe use¿ include a way of handling the endoscope to prevent damages in the bending tube.If the user follows the instruction, damages in the bending tube can be decreased.A review of the device history record found no deviations that could have caused or contributed to the reported issue.

• 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: 10057070
• MDR Text Key: 199137997
• Report Number: 8010047-2020-02702
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• 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: 04/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1