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

Model Number CYF-5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

The scope was returned to the service center however the evaluation is in progress.A review of the service history of the scope indicates the scope was purchased on (b)(6) 2019 with no repair history.In response to the user facility's request, the endoscopy support specialist (ess) visited the user facility to perform an in-service on leak testing and reprocessing.The ess discovered there was no leak tester on site.The facility has never purchased a leak tester for reprocessing.The ess informed the staff the importance of leak testing and it is a required step per manufacturer guidelines.Additionally, the ess performed an infection control in-service for the staff and recommended that the customer refer to the olympus instruction manual and ontrack forms for proper reprocessing instruction.The ess reviewed all proper reprocessing steps including and specifically focusing on leak testing with the staff.The user facility has requested to purchase a leak tester.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The service center was made aware that two patients cultured positive for salmonella.This is for report 2 of 2.

Manufacturer Narrative

The scope was sent to an independent laboratory for microbial testing.The test was completed but the test results are pending.The scope was ethylene oxide (eto) sterilized and returned to the service center for a device evaluation.A visual inspection was performed on the scope and found stains along the instrument channel wall and near the distal end opening (approximately 50mm).Additionally there are light stains near the control body side of the instrument channel.There was no foreign debris observed.The bending section cover was torn and the scope failed the leak test.The scope was previously purchased on (b)(6) 2019.The likely cause of the torn bending section cover is attributed to handling.The cause of the patient infection cannot be determined at this time, however, if additional information becomes available this report will be supplemented accordingly.

Manufacturer Narrative

This supplemental report is being submitted to provide the test results from the independent laboratory.The reported salmonella was not detected and the scope tested negative for culture.

Manufacturer Narrative

This supplemental report is being submitted to correct section d4 (serial number).

• 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
• MDR Report Key: 9238852
• MDR Text Key: 177841114
• Report Number: 8010047-2019-03713
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention