MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "CYF-V2", UK VERSION; FLEXIBLE VIDEO CYSTONEPHROSCOPE

Model Number CYF-V2

Device Problem Device Reprocessing Problem (1091)

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

Event Date 08/12/2022

Event Type  malfunction  

Event Description

It was reported the device was reprocessed without the end cap.The issue found during reprocessing.There is no patient involvement associated on this reported event.No user injury reported.

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation and inspection, service repair found leaking on a-rubber due to blown.The customer reported issue of "device was reprocessed without the end cap" was able to be confirmed.As noted in ifu or instruction for use , attach the sterilization cap to the endoscope before ethylene oxide gas sterilization.If a sterilization cap is not attached to an endoscope at the time of gas sterilization, air inside an endoscope may inflate, the bending part cover may rupture, and bending mechanism may be damaged.Furthermore, the following findings during inspection were noted on the device: peeling glue and residue on the objective lens.Torn bending rubber.The color code on the insertion tube is peeling.Leak in the scope.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the likely cause of the reported event is due to device handling.However, the root cause of the reported event is unable to be determined.The event can be prevented by following the instructions for use (ifu) which state: chapter 6 compatible reprocessing methods and chemical agents ·attach the sterilization cap to the endoscope before ethylene oxide gas sterilization.If the sterilization cap is not attached to the endoscope during ethylene oxide gas sterilization, the air inside the endoscope will expand and could rupture the bending section cover and/or damage the angulation mechanism olympus will continue to monitor field performance for this device.

• Brand Name: VIDEOSCOPE "CYF-V2", UK VERSION
• Type of Device: FLEXIBLE VIDEO CYSTONEPHROSCOPE
• 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: 15406287
• MDR Text Key: 300021510
• Report Number: 8010047-2022-12141
• Device Sequence Number: 1
• Product Code: NWB
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• 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: 09/16/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2010
• 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