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

Model Number URF-P6R

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

The device in question was returned for analysis.A visual inspection of the scope noted the bending section skeleton tab is protruding (sticking out) from the bending section cover near the insertion tube area.This particular section of the bending section cover is also missing a small portion (approximately 10%) that was not returned for evaluation.The bending section cover was removed and the bending section skeleton was found to be fully broken and separated, with no signs of any sharp edges.The skeleton tab that was protruding from the bending section cover is bent.The device was serviced and returned to the user facility.Further finding¿s include; excessive broken fibers (black dots) throughout the image, and a biopsy channel leak.Based on the evaluation, the likely cause of the bending section skeleton breaking is due to excessive force and/or stress, attributed to mishandling.The instruction manual states the following; ¿do not twist or bend the bending section with your hands¿.Additionally, the instructions manual for safe use 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 the investigation, the cause of the broken bending section skeleton and bent skeleton tab is most likely due to excessive force and/or stress attributed to user mishandling.If additional information becomes available, a supplemental report will be submitted.

Event Description

The user facility reported that the scope has a protruded broken skeleton.There was no patient injury reported by the customer for this event.

• 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: 8970648
• MDR Text Key: 213704464
• Report Number: 8010047-2019-03217
• 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: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• 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: 08/08/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2019
• 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