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

Model Number CYF-5

Device Problems Break (1069); Microbial Contamination of Device (2303)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to omsc but was returned to olympus (b)(4).(ofr).Ofr sent the device to a third party laboratory for microbiological testing.As a result of the testing, the sample collected from the all channels of the device tested positive for unspecified microbes (<1 cfu/endoscope).The testing result cleared the french guideline.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 as a result of multiple microbiological testing by the user facility, following microbes were detected from the sample collected from the device.[first time; (b)(6) 2020] -mesophile flora at 30 (3 cfu/100ml), non pathogenic environmental germs [second time; (b)(6) 2020] -mesophile flora at 30 (1 cfu/100ml), non pathogenic environmental germs [third time; (b)(6) 2020] -mesophile flora at 30 (1 cfu/100ml), non pathogenic environmental germs [fourth time;(b)(6) 2020] -mesophile flora at 30 (13 cfu/100ml), non pathogenic environmental germs the device had been manually reprocessed using peracetic acid.There was no report of infection associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus (b)(4).The evaluation of the device by (b)(4).Confirmed the following; the instrument channel port was not fixed and was deformed.The image guide bundle was broken.Omsc concluded that the instrument channel port deformation may have been caused by physical stress due to user handling or stress due to the removal of instrument channel parts during (b)(4) inspection.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of the reported event that the sample collected from the device tested positive as a result of microbiological testing could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

• Brand Name: FIBERSCOPE "CYF-5", EUROPEAN 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: 10893255
• MDR Text Key: 227878082
• Report Number: 8010047-2020-09349
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2011
• 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