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

Model Number CYF-5

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to omsc but was returned to olympus (b)(6) (ofr).For evaluation.Ofr inspected the device and confirmed the following; the adhesive on the bending section rubber had been peeled off.The fiber of the image guide bundle had been deteriorated.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) 2021: staphylococcus non-aureus (25 cfu/endoscope).Second time; (b)(6) 2021: staphylococcus non-aureus, ochrobactrum anthropi (total 2 cfu/endoscope).Third time; (b)(6) 2021: staphylococcus non-aureus, coccobacilli oxidase, acinetobacter (total 4 cfu/endoscope).The user facility did not provide other detailed information such as the reprocessing method.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) for evaluation.(b)(4) 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 (b)(6) guideline.From the device inspection result by (b)(4), omsc could not confirm the defect that caused the reported event.The instruction manual states the possibility of infection by insufficient reprocessing.The exact cause of the reported event could not be conclusively determined, because the result of microbiological testing by the third party laboratory cleared the (b)(6) guideline.However, based upon the past similar cases, the reported event may have been caused by the following: there was a difference in the reprocessing method of the device performed by the user facility and (b)(4).Contamination occurred during sample collection for microbiological testing.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.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: 11677477
• MDR Text Key: 268228293
• Report Number: 8010047-2021-05025
• 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: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• 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
• Date Manufacturer Received: 06/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1