MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The referenced scope was returned to the service center, however the evaluation is in progress.If additional information becomes available, this report will be supplemented accordingly.

Event Description

User reported reprocessing without the cap causing the rubber to be blown off of the tip of the scope.No patient involvement.

Manufacturer Narrative

The senior supply coordinator for central sterile processing (csp) department at the facility reported the scope was not used on patients after it was broken and there were no patient infections as a result of the event.Additionally, the ear nose & throat operating room (or) coordinator reported that if the cap was not placed on the scope for processing it was disinfected properly according to csp standards.Once it was done being used in the or, it was flushed at the end of the cases with sterile water and wiped with a wet 4x4.Then it was sent to csp for further cleaning.

Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr# 8010047-2020-2232.The original equipment manufacturer (oem), omsc, performed a device history record review and no abnormalities were noted.No device was returned to the oem, however, an investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.Based on the information provided, the potential root cause has been determined to be incorrect gas sterilization, reprocessed without using eto cap.The bending section cover may have ruptured by the difference of air pressure between inside and outside of the scope while sterilized by gas.The instructions for use (ifu) instructs to attach the eto cap when conducting gas sterilization.The event was preventable by conducting reprocessing in accordance with ifu.The product¿s ifu (operation manual) describes the following: "6.5 eto gas sterilization" attach the eto cap to the endoscope connector before sterilizing.If the eto cap is not attached on the endoscope during sterilization, the vacuum created within the sterilization chamber can rupture the covering of the bending section."inspection of the endoscope" visually inspect the external surface of the entire insertion tube for dents, bulges, swelling, peeling or other irregularities.Holding the insertion tube gently with a hand carefully run your fingertips over the entire length of the insertion tube in both directions (see figure confirm that there is no object stopping the hand or protruding objects or other irregularities.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• 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: 9965150
• MDR Text Key: 213462626
• Report Number: 8010047-2020-02232
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339417
• UDI-Public: 04953170339417
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: No
• 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