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 Unspecified Infection (1930)

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 february 23, 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 on track 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 1 of 2.

• 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: 9238667
• MDR Text Key: 177366701
• Report Number: 8010047-2019-03712
• 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,HEALTH
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• 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
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/14/2020
• Was Device Evaluated By Manufacturer?: No
• 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: 10/25/2019 Patient Sequence Number: 1