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

Model Number CYF-VA2

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 07/13/2017

Event Type  Injury  

Manufacturer Narrative

This device referenced in this report has been returned to olympus medical systems corp.For repair and it is under evaluation.The service record does not state that there are scratches on the wall of the channels of the subject device.At the user facility, there were 4 patients infection with pseudomonas having undergone a cystoscopy with cyf-va2 from (b)(6) in 2016.Please refer to the mdr's: #8010047-2016-01229, #8010047-2016-01230, #8010047-2016-01231 and #8010047-2016-01232.The subject device has been reportedly cleaned and disinfected after procedures, and sometimes sterilized.The manufacturing record of the device was reviewed without irregularity related to this event.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available at a later time, this report will be supplemented.

Event Description

Olympus was informed that a hospitalized patient having undergone a cystoscopy was infected with pseudomonas after several days from the procedure.Symptoms and outcomes of the patient are unknown.The user facility is investigating if there is any patient who has symptoms of infection because the subject device has been used for other outpatient(s).As the infection source has not been identified, the user is reportedly investigating not only the subject device but other infection source.

Manufacturer Narrative

This device referenced in this report has been returned to olympus medical systems corp.For evaluation.During the evaluation, it was confirmed that the insertion tube was kinked, and no other anomaly was found.The exact cause could not be conclusively determined.

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
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 6772985
• MDR Text Key: 82010442
• Report Number: 8010047-2017-01185
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other