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

Model Number URF-P6

Device Problem Optical Problem (3001)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center.A visual inspection on the received condition was performed and found a portion of the bending section skeleton protruding out from the bending section cover near the insertion tube side.The bending section damage is approximately 70mm from the distal end side, which is causing a leak on the bending section cover.The bending section cover was removed in order to reveal the extent of the damage.Upon removal of cover, it was confirmed that the bending section skeleton is fully separated producing sharp edges near the insertion tube side.The bending section support pins are still intact and not lifted.The scope was previously refurbished (28f) on june 20th 2019.Further finding¿s include; excessive broken fibers (black dots) throughout the image, a c-body leak and corroded bending section.Based on the evaluation of the returned device, the most likely cause of the broken fibers and bending section skeleton breaking is due to excessive force and/or stress, attributed to user mishandling.The instructions for use contains the following warnings to prevent equipment damage and patient injury: "do not twist or bend the bending section with your hands.Equipment damage may result; do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damage.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

The user facility reported that the device in question has broken fibers (ig fiber breakage).During service activities the bending skeleton was noted to be broken with metal protruding.There was no patient involvement or adverse outcome reported as a result of the 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 8985525
• MDR Text Key: 200446621
• Report Number: 8010047-2019-03248
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• 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: 08/13/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2019
• 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