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

Model Number CYF-VHA

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

Patient Problem Sepsis (2067)

Event Date 10/18/2018

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation. There was no malfunction report of the subject device. Since the serial number of this device is unknown and omsc could not confirm the manufacturing history. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp. (omsc) was informed that a patient developed sepsis after a cystoscopy using the subject device. The patient was discharged from the user facility after the cystoscopy, but the patient visited the hospital again due to difficulty in urination and was diagnosed with sepsis. Dialysis was carried out for the patient hastily. The user facility commented that urinary tract¿s infection was possibly caused by the cystoscopy and resulted in the sepsis. The user facility reprocessed the subject device using olympus automated endoscope reprocessor model oer-s (not available in the usa. ) the outcome of the patient is currently unknown.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 8072879
• MDR Text Key: 127208417
• Report Number: 8010047-2018-02206
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: DISTRIBUTOR,HEALTH PROFESSION
• Reporter Occupation: BIOMEDICAL ENGINEER
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 11/15/2018
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CYF-VHA
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• 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: 11/15/2018 Patient Sequence Number: 1