MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE; CYSTOSCOPE, FLEXIBLE

Model Number CYF-5

Device Problem Microbial Contamination of Device (2303)

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

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Olympus was informed that during a routine surveillance culturing test by the facility, this device tested positive for unspecified bacteria(1 cfu/100ml).The facility had manually reprocessed the subject device using peracetic acid.There was no report of patient infection associated with this report.The customer reported that they followed instruction/french regulations reprocessing and the subject device was reprocessed according to the instruction of manufacturer.

Manufacturer Narrative

This supplemental report is being submitted to provide evaluation result of the subject device by the manufacturer.Omsc reviewed the manufacture history of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.If additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation result.The subject device has not been returned to olympus medical systems corp.But was returned to olympus (b)(4).(b)(4) sent this device to a third party laboratory for additional microbiological testing.In the additional test, the biopsy channel tested positive for staphyloccocus coagulase negative(1 cfu/100ml) and the testing result did not clear the (b)(4) guideline.After reprocessing for the subject device, additional microbiological testing was conducted again; the testing indicated no microbial growth for the subject device.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: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTOSCOPE, FLEXIBLE
• 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: 7039775
• MDR Text Key: 93431489
• Report Number: 8010047-2017-01796
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/26/2017

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
• Other Device ID Number: 04042761051453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 11/10/2017; 12/11/2017
• Supplement Dates FDA Received: 12/05/2017; 12/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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