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

Model Number CYF-VHA

Device Problem Fail-Safe Problem (2936)

Patient Problem Blood Loss (2597)

Event Date 05/23/2017

Event Type  Injury  

Manufacturer Narrative

The subject device was returned to omsc.The evaluation of the subject device by omsc confirmed following defects.- there were kinked and sneaky on the bending section.- there were cracked and scratches on the rubber of the bending section.The phenomenon did not reproduce.The exact cause of the reported phenomenon could not be determined conclusively at present.

Event Description

Olympus medical systems corp.(omsc) was informed that during the examination, the bending section of the subject device was angulated and the doctor couldn't release the angle.The doctor anesthetized additionally.It took two hours to withdraw the subject device from the patient.There was slight bleeding during withdrawing the subject device.Although there was slight bleeding and the patient's blood pressure had risen, doctor judged that there was no need for taking medical treatment.In 2014 the patient underwent surgery to remove the prostate completely.And the urethra was confirmed to be stricture during the follow-up diagnosis.The doctor informed the following.- there was no abnormality in the bending section of the subject device during inserting it.- the doctor didn't confirm whether angulation lock was engaged.

Manufacturer Narrative

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

• Brand Name: 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: 6659487
• MDR Text Key: 78135754
• Report Number: 8010047-2017-00766
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CYF-VHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2017
• Initial Date FDA Received: 06/22/2017
• Supplement Dates Manufacturer Received: 01/29/2019
• Supplement Dates FDA Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 78 YR