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

Model Number URF-V2

Device Problems Break (1069); Material Perforation (2205)

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

Event Date 01/31/2017

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus medical systems corp.But was returned to (b)(4).(b)(4) confirmed the reported device damage.(b)(4) found that the bending section of the subject device broke at the insertion tube side, an inner part of the bending section was protruding from the bending rubber.There was a hole in the bending rubber of the subject device and the subject device failed the water leakage test.The manufacturing record of the subject device was reviewed with no irregularity related to the phenomenon.The exact cause of the event could not be concluded at this moment.If additional and significant information becomes available, this report will be supplemented.

Event Description

Olympus was informed that the bending function of the subject device did not work properly during an ureteroscopy.There was no report of patient injury associated with this event.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 8142642517
• MDR Report Key: 6360059
• MDR Text Key: 68760352
• Report Number: 8010047-2017-00205
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: PK072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 2429304-12/12/2016-041C
• Patient Sequence Number: 1