MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-V2

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2017

Event Type  Malfunction  

Manufacturer Narrative

This device referenced in this report has not been returned to olympus medical systems corp. For evaluation, but returned to olympus keymed (okm) in (b)(4). The subject device was sold on (b)(6) 2014, and the last serviced on june 13, 2017 for a leaking in universal cord. During the investigation by okm, it was confirmed that the subject device passed water leak test. It was also confirmed that the boot of the subject device was loose and the insertion tube could rotate. The boot was removed for further investigation and it was confirmed that the nut to fix the insertion tube to control section was loose and the insertion could rotate the failure of the previous repair could not be ruled out as a contributory factor of the reported event.

Event Description

Olympus was informed that when the user angulated the insertion tube of the subject device, the insertion tube rotated during a bladder inspection. The user removed the subject device from the patient and replaced with another device. The procedure was completed. There was no patient injury reported and the patient was reportedly fine.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 6854339
• MDR Text Key: 87227676
• Report Number: 8010047-2017-01324
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,USER FACILITY
• Reporter Occupation: HEALTH PROFESSIONAL
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 09/11/2017
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Device MODEL Number: CYF-V2
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 09/01/2014
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse