MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "CYF-V2", EUROPEAN VERSION; CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-V2

Device Problem Material Perforation (2205)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation.During the visual inspection, the bending section cover was found damaged.Functional testing was performed finding no issues.The reported event was confirmed.The most likely cause of the damaged bending section was due to unintended use error of the device.

Event Description

Olympus received a complaint from a user facility stating that during reprocessing, the bending section covering was found to be ruptured.There was no patient involvement.Additional information could not be obtained.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information and device manufacturer date.Please see the updates in sections: g4, g7, h2, h6, and h10.The legal manufacturer reviewed the content of this complaint for further investigation.The legal manufacturer reported that the root cause could not be determined.The lm confirmed that the subject device was shipped in accordance with specifications via dhr.The lm reported that the most probable causes for the reported event are as follows: since there was no information from the user, it is difficult to specify the cause.As mentioned in the sales business center (sbc) investigation results, performance of reprocessing on the device is secured by conducting appropriate reprocessing.We would like the user to conduct reprocessing in accordance with ifu.

• Brand Name: VIDEOSCOPE "CYF-V2", EUROPEAN VERSION
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10049319
• MDR Text Key: 222564329
• Report Number: 8010047-2020-02666
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CYF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2020
• Initial Date FDA Received: 05/12/2020
• Supplement Dates Manufacturer Received: 11/08/2020
• Supplement Dates FDA Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1