MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc but was returned to olympus (b)(4).(b)(4) sent the subject device to a third party laboratory for microbiological testing and the testing indicated no microorganisms growth for the subject device.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 during a routine surveillance culturing conducted by the user facility, the subject device tested (b)(6) for unspecified microorganism.The facility also informed that the subject device was re-tested twice, and the subject device tested (b)(6) for the following some kinds of bacteria.First time: (b)(6) (total of microbial colony count 5 cfu/ endoscope).Second time: (b)(6) (1cfu/endoscope).There was no report of infection associated with this report.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• 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: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6960657
• MDR Text Key: 90699387
• Report Number: 8010047-2017-01499
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2016
• 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