MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS CYSTO VIDEOSCOPE; CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-240A

Device Problems Obstruction of Flow (2423); Device Damaged by Another Device (2915)

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

Event Date 08/01/2022

Event Type  malfunction  

Manufacturer Narrative

This device not sold in the us but a similar device is.Full address of the facility is (b)(6).The device is returned and an evaluation completed for it.The user¿s complaint was confirmed.Upon inspection of the device, it was observed that there was a small body (brush) stuck in the channel tube.Other observation for the device is that due to wear of angle wire, bending angle in up direction does not meet the standard value.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

As reported for this event by the customer, during manual cleaning of the device, the cleaning brush broke off in the device.The broken piece of the brush was stuck in the biopsy mouthpiece and could not be removed by formal reprocessing method.The cleaning brush was not an olympus brush.There is no patient involvement and no harm reported to any patient.

Manufacturer Narrative

Additional information has been received from the customer.This supplemental report is being submitted to provide this information.An air water channel cleaning adapter is not used for pre-cleaning.Pre-cleaning is performed immediately after a procedure by cleaning with detergent and water.Detergent brand is not provided.Pre-cleaning steps are wipe, suction, and brush.The endoscope channels are brushed during manual cleaning with a china brand single use brush that is not re-used.For this event, the device was not placed in the oer-aw or other reprocessing unit (since brush broke during manual cleaning).Information for automatic endoscopy reprocessor (aer) and storage is not provided since it was not relevant to his event.After the event occurred, the device was wrapped in container and dried without disinfecting.

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 14 years since the subject device was manufactured.Based on the results of the investigation, the event likely occurred due to the customer using a non-olympus cleaning brush which was broken during use and lodged in the biopsy channel.However, a definitive root cause could not be determined at this time.The user can detect the event by handling the device in accordance with the instructions for use (ifu): "instrument compatibility: be sure to thoroughly brush the inside of the instrument channel, the instrument channel port, the suction channel, and the suction cylinder of the endoscope.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS CYSTO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15293712
• MDR Text Key: 305528990
• Report Number: 9610595-2022-01295
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2022

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-240A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/25/2022
• Supplement Dates Manufacturer Received: 08/26/2022; 09/20/2022
• Supplement Dates FDA Received: 08/26/2022; 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2008
• 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