MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FLEXIBLE CYSTOSCOPE

Model Number CYF-5

Device Problem Microbial Contamination of Device (2303)

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

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) but was returned to olympus (b)(4).(b)(4) sent the subject device to a third party laboratory for an additional microbiological testing.In the additional test, the instrument channel of the subject device tested (b)(6) for bacillus spp and (b)(6) (2cfu/100ml).The testing result did not clear (b)(4) guideline.(b)(4) detected some scratches inside the instrument channel of the subject device during the inspection.(b)(4) is planning to perform an additional microbiological test.If olympus receive any additional information, a supplemental report will be submitted to update.

Event Description

Olympus was informed that as a result of the routine microbiological test by the user facility, the subject device tested positive for unspecified bacteria (3 cfu/87ml).There was no report of patient infection associated with this event.The customer reported that they followed the cleaning and disinfection process specified in the (b)(4) guidelines and the instruction manual.In addition, the subject device was disinfected using peracetic acid.

Manufacturer Narrative

This supplemental report is being submitted to provide evaluation results of the subject device.An additional microbiological test was conducted again at the third party.In the second additional test, the testing indicated no microbial growth for the subject device.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 at this time.If additional information is received, this report will be supplemented.

• Brand Name: FLEXIBLE CYSTOSCOPE
• Type of Device: FLEXIBLE CYSTOSCOPE
• 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: 7094684
• MDR Text Key: 95737978
• Report Number: 8010047-2017-01947
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 12/20/2017
• Supplement Dates FDA Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2015
• 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