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

Model Number CYF-5

Device Problems Accessory Incompatible (1004); Device Reprocessing Problem (1091)

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

Event Date 12/08/2021

Event Type  malfunction  

Event Description

As reported, cyf-5 incorrect tubing used during reprocessing.Connecting tube maj-1904 (for the oer pro scope washer) was observed to be used during a reprocessing cycle in the aer (oer pro).Fse (field service engineer) had customer stop the cycle and advised that the correct connecting tube is maj-1515.There is no patient involvement associated on this reported event.No user injury reported.

Manufacturer Narrative

The fse (field service engineer) onsite advised customer that the correct connecting tube is maj-1515, per "list of compatible endoscopes/connecting tubes for oer pro".Customer were provided with the list.In a follow up communication with the customer, it was conveyed that customer confirmed that they already have the correct connecting tube.Customer stated they obtained the maj-1515 which is the correct connecting tube.Customer stated at the time of the event since they have to stop using the washer, they were able to continue cleaning the scope using manual cleaning and disinfection.Customer confirmed no patient involvement, no user injury.No further information provided.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.It has been over 10 years since the subject device was manufactured.Based on the results of the investigation, the cause of using the incorrect tubing during reprocessing was likely human error.The following information is stated in the instructions for use which may have prevented the event: "warning.Using incompatible tubes will compromise the effectiveness of the reprocessing." olympus will continue to monitor field performance for this device.

• 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: 13121626
• MDR Text Key: 284200073
• Report Number: 8010047-2021-16986
• Device Sequence Number: 1
• Product Code: FAJ
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

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-5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/14/2022
• Supplement Dates FDA Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2011
• 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
• Treatment: MAJ-1904OER PRO