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

Model Number CYF-VA2

Device Problem Insufficient Information (3190)

Patient Problem Urinary Tract Infection (2120)

Event Date 04/06/2018

Event Type  Injury  

Manufacturer Narrative

The subject device was a loaner device of olympus.After the event, the subject device was returned to olympus repair center for evaluation.The evaluation confirmed no irregularity in the subject device.Omsc reviewed the manufacture history of the subject device and confirmed no irregularity the exact cause could not be determined at present.If significant additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that a patient developed a fever after having undergone a diagnostic cystoscopy as an out-patient with the subject device.It was reported that the patient was diagnosed as an infection with pseudomonas aeruginosa and was hospitalized for a treatment with antibiotic.After the treatment, the patient recovered from the infection and was discharged from the user facility.It was reported that the facility reprocessed the subject device using an olympus endoscope reprocessor model oer-4 (not available in the usa) before the cystoscopy.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code" and "pma/510(k) number".

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7536181
• MDR Text Key: 108979666
• Report Number: 8010047-2018-00925
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-VA2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other