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

Model Number CYF-5R

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

Patient Problem Bacterial Infection (1735)

Event Date 01/07/2019

Event Type  Injury  

Manufacturer Narrative

The device was returned to olympus is pending evaluation and microbial testing. The scope will be sent to an independent laboratory for microbial testing. As part of our investigation, on february 04, 2019 an olympus endoscopy support specialist (ess) was dispatched to the user facility to observe the facility¿s reprocessing practices and provide training if necessary. Upon arrival the ess was informed that the facility did not have a leak tester and wanted the in-service/observation to be rescheduled for a later date. To date the user facility has not finalized date for this visit. If additional information received this report will be supplemented accordingly.

Event Description

Olympus was informed that two patients developed kelbsiella pneumonia infections after undergoing cystoscopy procedures using two of the facility¿s cystonephrofiberscopes ((b)(4)). The patients were treated with intravenous antibiotics. In addition, the user facility reported that they use enzyme and aldahol cleaner to disinfect and clean the scope. The minimum effective concentration is being checked every 2 weeks. The endoscope channel is being brushed during manual cleaning using a reusable brush (model: unk). The scope is precleaned immediately after the procedure as it is rinsed, flushed, soaped and the steps are then repeated. The scope is not being leaked tested prior to manual cleaning. Air is flushed into the scope after reprocessing. There is no known issue with the facility¿s automatic endoscope reprocessor (aer) (model: unk). The facility¿s last in-service with an olympus endoscopy support specialist was conducted on feb 5, 2019. There have been no changes to the facility¿s reprocessing staff since the last in-service. The user facility reported that all the reprocessing staffs were trained on how to properly reprocess an endoscope. This is 2 of 2 reports.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8364744
• MDR Text Key: 136990199
• Report Number: 2951238-2019-00452
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 02/24/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CYF-5R
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/15/2019
• 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 TREATMENT DATA

Date Received: 02/24/2019 Patient Sequence Number: 1