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

Model Number CYF-5

Device Problem Microbial Contamination of Device (2303)

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

Event Date 08/12/2021

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed that as a result of routine microbiological testing by the user facility, following microbes were detected from the sample collected from the subject device.Instrument channel: paenibacillus sp.(1 cfu/endoscope).The device had been manually reprocessed using peracetic acid.There was no report of infection associated with this report.

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation but was returned to olympus europa se & co.Kg (oekg).The evaluation is in progress currently.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.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device 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.The device was evaluated at (b)(4).As a result of the evaluation, it was confirmed that the adhesive of the bending section rubber was peeled off.The exact cause of the reported event could not be conclusively determined.Based on the following investigation results, it is unlikely that the culture test result was positive due to a device malfunction.The causal relationship between the reported event and the repair location was unclear, as perforations were confirmed in the instrument channel but the location where the bacteria were detected could not be identified.Samples were collected from all channels after (b)(4) reprocessed the device according to the instruction manual.The culture test results for the collected samples were negative.Olympus medical systems corp.(omsc) confirmed that the instruction manual of the device describes the reprocessing procedure.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: 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: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12472096
• MDR Text Key: 280876743
• Report Number: 8010047-2021-11724
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2017
• 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