MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "CYF-5", EUROPEAN VERSION; CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problems Complete Blockage (1094); Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Patient Involvement (2645)

Event Date 05/14/2020

Event Type  malfunction  

Manufacturer Narrative

Device was returned for evaluation.Evaluation of the device found a foreign object stuck inside the biopsy channel.An olympus boroscope was used to check the device biopsy channel and found that a broken piece of the foreign object was found lodged inside the biopsy channel approximately 40mm from the distal end side of the device.A brush or forcep was not able to pass through the biopsy channel due to the foreign object stuck inside.The foreign object was not able to be removed.In addition, leaking was observed in the channel.Based on evaluation findings, the reported issue was confirmed.The root cause of the issue was due to the wrong brush used to clean the scope, which became stuck in the device biopsy channel.The root cause of the issue was attributed to use error.In addition, as a preventive measure and as stated on the ifu : the channel cleaning brush is a consumable item.If the brush head is bent or kinked during use, the distal end of the brush may be damaged or come off.Confirm that the brush is free from any damage or irregularities before and after each use.Should a part of the brush come off, immediately retrieve it and carefully confirm that no parts are left inside the channel of the endoscope by passing a new cleaning brush or other endo-therapy accessory through it.Any parts left in the channel may drop into the patient during the procedure.Depending on the location, the missing part may not be recoverable by passing a new brush or other endo-therapy accessory through the channel.In this case, contact olympus.

Event Description

It was reported that during reprocessing, the brush became stuck in the scope.According to the reporter, the brush was unable to be removed as the wrong brush was used to clean the scope.There was no patient involvement on this report, no user harm or injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the review of the device history records (dhr).Please see updated sections.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The device history records (shipment test record) was reviewed and the product was shipped under normal conditions.Root cause of the issue was due to use error, maintenance and device handling issue.The user used an incompatible, off label cleaning brush and this likely caused the brush to get stuck in the forceps channel resulted in the device failure during sterilization.

• Brand Name: FIBERSCOPE "CYF-5", EUROPEAN VERSION
• 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: 10119020
• MDR Text Key: 223217197
• Report Number: 8010047-2020-03108
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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