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

Model Number URF-V

Device Problems Hole In Material (1293); Material Perforation (2205); Cut In Material (2454)

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

Event Date 04/11/2016

Event Type  malfunction  

Manufacturer Narrative

This device referenced in this report has been returned to olympus and the evaluation is ongoing.The manufacturing record of the device was reviewed with no irregularity found.If additional information becomes available at a later time, this report will be supplemented.

Event Description

The subject device was used for an ureterorenoscopy to crush stones.During the procedure, the wire stuck out of the bending rubber.The user facility completed the procedure using the subject device.According to the surgeon, at the beginning of the procedure, there was no damage to the subject device recognized.There was no serious patient injury reported, but further information was not provided.

Manufacturer Narrative

This report is submitted to report the evaluation result of the subject device.The evaluation found that a part of the braid lines protruded from the bending section.The bending section of the subject device has a braid under the bending rubber; the braid is a tube-like part of mesh which is woven of multiple braid lines.Some of the braid lines running to only top-right direction from the distal end of the subject device had a buckling and fracture, while the braid line running to down-right direction had no buckling and fracture.The exact cause could not be conclusively determined, but from the damage of the braid lines, it was likely caused by fracture of the braid lines which was caused by an excessive torque applied from a single direction to the bending tube.For example, during an approach to lesion in the renal calyx or whatever, if the control section is forcibly rotated with angulated, the bending tube is expected to be subject to an excessive torque.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 6425177
• MDR Report Key: 5681038
• MDR Text Key: 45960656
• Report Number: 8010047-2016-00671
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K#: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V
• Device Catalogue Number: URF-V
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2009
• 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