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 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation but was returned to olympus (b)(4).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.

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.-coagulase-negative staphylococci (5 cfu/endoscope) the device had been reprocessed with an olympus automated endoscope reprocessor, model etd4/etd3 (not available in the usa), 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 subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus (b)(4).(b)(4) sent the device to a third party laboratory for microbiological testing.As a result of the testing, no microbe was detected from the sample collected from all channels of the subject device.The testing result cleared the (b)(6) guideline.(b)(4) checked the subject device and found the following.The insertion tube was pinched.The control unit was corroded.The instrument channel was scratched and deformed.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the information from the user and (b)(4), omsc considered that the reported phenomenon was less relevant to the subject device.If additional information is received, 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: 12403520
• MDR Text Key: 280820019
• Report Number: 8010047-2021-11048
• 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: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• 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: 08/06/2021
• 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: 09/18/2018
• 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