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

Model Number CYF-VH

Device Problems Crack (1135); Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The report is being submitted to provide the customer's report of the event as well as investigation findings.The device referenced in this report has been evaluated by olympus.Physical evaluation of the complaint device reveals: the device failed the leak test due to detached instrument channel port.The rubber glue is cracked and there is peeling cement on the lens.The lens has minor scratches.The insertion tube has a minor dent.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: chapter 9 storage 3.4 inspection of accessories inspection of the forceps/irrigation plug ¿ if any irregularity is observed on the biopsy valve of the forceps/irrigation plug, replace it with a new biopsy valve.A damaged or deformed biopsy valve can reduce the efficacy of the air/water feeding function and may cause fluid to leak or spray from the forceps port of the forceps/irrigation plug.Conclusion: the definitive cause of the user's experience could not be determined.Based on the available information, the following are presumed to be possible causes: the t-tube mounting cap (instrument channel port) was subjected to excessive external force when attaching or detaching the t-tube (forceps/irrigation plug), which may have resulted in damage (loosening or deformation.In addition, 8 years and 4 months had passed since manufacturing of the device and it may have been affected by aging/use degradation.

Event Description

It was reported during reprocessing of a cysto-nephro videoscope, the biopsy port pulled out.There was no patient contact/impact related to this occurrence.

• 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 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11423855
• MDR Text Key: 244559468
• Report Number: 8010047-2021-03376
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411250
• UDI-Public: 04953170411250
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2021

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-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2012
• 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