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

Model Number CYF-V2

Device Problems No Display/Image (1183); No Device Output (1435)

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

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

This device referenced in this report has not been returned to olympus medical systems corp.For evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available at a later time, this report will be supplemented.

Event Description

Olympus was informed that the subject device did not display image when it was used for an unspecified therapeutic procedure.It was also reported that a pin, one of the component of the venting connector, was missing and there was rust at the venting connector.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.But was returned to olympus (b)(4).It was confirmed during performed investigation that the malfunction of the image, the connecting tube was heavy kinked, and the venting connector¿s pin was broken.The manufacturing record of the subject device was reviewed with no irregularity.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• 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 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6802975
• MDR Text Key: 83222462
• Report Number: 8010047-2017-01212
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CYF-V2
• Other Device ID Number: 04042761066778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2012
• 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