MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE, "CYF-5", UK VERSION CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Break (1069)

Patient Problem Unspecified Infection (1930)

Event Date 07/15/2019

Event Type  Injury  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp. (omsc) but was returned to (b)(4) for evaluation and repair. The evaluation is in progress. 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 three patients were infected with pseudomonas after cystoscopy using the subject device. In addition, it was reported that one of three patients died. However, the relationship between the death and subject device and the infection is currently unknown. The two patients¿ condition other than the expired patient is currently unknown. The user facility returned the subject device to olympus for repair because the subject device did not pass a leakage test. The user facility had cleaned the subject device using a non-olympus single use cleaning brush (mi-cb-sweep-port, cantel) and reprocessed the subject device using a non-olympus automated endoscope reprocessor (medivators rapidaer, cantel), using a non-olympus disinfectant (rapicide part a and rapicide part b, cantel). Omsc is submitting three medical device reports according to the number of the infected patients. This is two of three reports.

• Brand Name: FIBERSCOPE, "CYF-5", UK VERSION
• 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: 8854169
• MDR Text Key: 153068302
• Report Number: 8010047-2019-02806
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: UK
• PMA/PMN Number: K032092
• 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
• Report Date: 10/17/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/02/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CYF-5
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/07/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 09/06/2012
• 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: 08/02/2019 Patient Sequence Number: 1