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 has not been returned to the manufacturer for evaluation.All the information reported was obtained from the user facility.If additional information becomes available at a later time, a follow-up report will be submitted.

Event Description

The user facility reported that during the reprocessing cycle of the scope, the bending rubber was blown off due to the gas cap not being attached properly.No additional information was provided.

Manufacturer Narrative

The device was returned, upon evaluation the device did not pass the leak test due to a torn bending rubber.A crack on the video connector plug was found during visual inspection.The reported issue was confirmed and caused physical damage to the device.An investigation was completed by the original equipment manufacturer (oem) and determined that there is no manufacturing, material or processing related cause for this failure mode.The root cause has been determined to be an unintended use error during reprocessing of the device.Upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.If additional information is obtained a supplemental report will be submitted.

• 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: 10140732
• MDR Text Key: 218498847
• Report Number: 2951238-2020-00453
• 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: 10/20/2020

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: Health Professional
• Device Model Number: CYF-V2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1