MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "CYF-5A", WITH SUCTION, EUROPEAN VERSION; OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5A

Device Problem Microbial Contamination of Device (2303)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to olympus medical systems corp.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus was informed that the subject device tested positive for klebsiella multiresistance during routine surveillance culturing test by the facility.The number of the microbes and the portion of the subject device, where the microbes were detected, was not reported.The subject device had been disinfected using non-olympus automated endoscope reprocessor (soloscope series3).There was no report of patient infection associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the user facility.The facility informed that the patient was infected with klebsiella multiresistencia before the procedure using the subject device, and the subject device broke without causing harm to the patient during the procedure.The facility reported that they sent the subject device to olympus for sterilizing and repair service without using it for another patient.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide the evaluation result of the device.The subject device had not been returned to olympus medical systems corp.But was returned to olympus (b)(4).The subject device was sent to a third party laboratory for additional microbiological testing.In the additional test, the testing indicated no microbial growth for the subject device.In the evaluation results of the subject device, there were the following abnormalities.The connecting tube and bending tube squeezed and kinked at several times.The four fibers of the image guide bundle were broken.The air valve unit was rotatable.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

• Brand Name: FIBERSCOPE "CYF-5A", WITH SUCTION, EUROPEAN VERSION
• Type of Device: OES CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7551860
• MDR Text Key: 109768040
• Report Number: 8010047-2018-00947
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CYF-5A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1