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

Model Number CYF-V2

Device Problems Peeled/Delaminated (1454); Material Too Rigid or Stiff (1544)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated.The device evaluation found the customer reported issue was confirmed.The bending section was found stiff when angulated due to heavy lever.The control knob movement was observed to be heavy when angulating the ¿a-lever¿.Insertion tube was found with continuous peeling on the markings.Peel was noted on ¿a-rubber¿ glue.Minor scratches were observed on the video cable, light guide tube and distal end cover.Investigation is ongoing.This report will be supplemented accordingly following investigations.

Event Description

It was reported that the device bending section is stiff and does not return to neutral position.The issue was found during reprocessing.There was no patient involvement, no user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g3, g6, h2, h4, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Service repair record review showed the following repair record on (b)(6) 2020 for a-rubber replacement, m-case unit replacement, light guide tube replacement.Conclusion: unable to identify a root cause.Based on investigation and information gathered, the following was confirmed.·bending section is stiff and does not return to neutral ·confirmed that a-rubber is stiff and heavy on angulation.·a-rubber glue and insertion tube peeling were confirmed.·unable to identify that the breakage was attributed to whether the stress or handling.·manufacturing record shows no abnormalities on shipment.Unable to identify that the stiff bending section was attributed to whether the excessive stress or improper handling from the above facts.Olympus will continue to monitor complaints for this device.

• Brand Name: VIDEOSCOPE "CYF-V2", UK 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12014255
• MDR Text Key: 271794322
• Report Number: 8010047-2021-07620
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339431
• UDI-Public: 04953170339431
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2013
• 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