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

Model Number CYF-V2R

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received for evaluation.Evaluation determined that the device was found with a torn ¿a-rubber¿.Leak testing was unable to be performed due to blown ¿a-rubber¿ unit.The rubber glue was observed to be a non-olympus unit along with insertion tube, lg (light guide) tube both units were determined to be a non-olympus.A missing ring was found on the control body and a cracked m-case was observed on the video connector.The identified parts needs to be replaced.Device was placed for repair.Based on evaluation findings, the reported issue was confirmed.The root cause of the issue were attributed to users handling, maintenance issue.

Event Description

It was reported that device was found with exploded sheath.The issue occurred during a reprocessing.There was no patient involvement on this report.No user harm or injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr) and investigation conclusion.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Based on investigation results, it was confirmed that there was a third party repair performed on the device and it is not possible to guarantee the safety of the current product, as it is impossible to confirm the material used, and it is impossible to confirm the biocompatibility.Repairs by the 3rd party are prohibited in the instruction manual.As stated on the instruction for use and as a preventive measure: the instrument does not contain any user-serviceable parts.Do not disassemble, modify, or attempt to repair it; patient or operator injury and/or equipment damage may result.Equipment that has been disassembled, repaired, altered, changed, or modified by persons other than olympus¿ own authorized service personnel is excluded from olympus¿ limited warranty and is not warranted by olympus in any manner.Olympus will continue to monitor complaints for this device.

• 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 192-8 507; JA 192-8507
• MDR Report Key: 10653151
• MDR Text Key: 223662728
• Report Number: 8010047-2020-07430
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411212
• UDI-Public: 04953170411212
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-V2R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1