MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VH

Device Problems Microbial Contamination of Device (2303); Material Integrity Problem (2978)

Patient Problems Bacterial Infection (1735); Sepsis (2067)

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the service center for evaluation. The user facility did not provide a specific serial number for the subject; therefore, no review of the instrument history can be performed. Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported events. If additional information becomes available, this report will be updated and supplemented accordingly. The cyf-vh ¿reprocessing before the first use/reprocessing and storage after use¿ section of the instruction manual warns users after using this instrument, reprocess and store it according to the instructions given in the endoscope¿s companion reprocessing manual. Improper and/or incomplete reprocessing or storage can pose an infection control risk, cause equipment damage, or reduce performance. ¿.

Event Description

The service was informed that six patients contracted salmonella infections in their bladder after undergoing cystoscopy procedures with the facility¿s cysto-nephro videoscope. The user facility¿s physician reported that this has led to sepsis in some of the patients. The bacteria has been tested and found to be the same genetic bug in each case. The user facility has identified 35 additional patients that will need to be notified as they also were in contact the subject scope. All patients were seen at the same clinic. In addition, the physician reported that the scope passed the leak test and appeared in satisfactory condition upon quick visual inspection. The facility performed a closer visual inspection on the subject scope and observed break, separation or perforation along the insertion tube of the scope; where the uppermost point of the bending rubber begins and meets the bending section bending rubber. The scope was then cultured and tested positive for salmonella. This is 2 of 6 reports.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8701627
• MDR Text Key: 148201933
• Report Number: 2951238-2019-00940
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: CA
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/14/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 06/14/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CYF-VH
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/17/2020
• 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 TREATMENT DATA

Date Received: 06/14/2019 Patient Sequence Number: 1