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

Model Number CYF-5A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

The device was returned to olympus medical systems corp. (omsc) for evaluation. Omsc will start evaluating the device. There were no further details provided. If significant additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp. (omsc) was informed that five patients developed cystitis after procedures using this product. The device had been reprocessed by an non-olympus automated reprocessing machine espal. According to the user facility, the manufacturer has confirmed the reprocessing machine has no problem. Therefore, the user facility suspects that the olympus endoscope caused the patient infections and contacted olympus to ask for investigation. A total of five reports are being submitted for the five patients. This is the 2nd of 5 reports.

• 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: 10716973
• MDR Text Key: 212559981
• Report Number: 8010047-2020-07992
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: JA
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: USER FACILITY

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/24/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/22/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CYF-5A
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/15/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 10/02/2018
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient TREATMENT DATA

Date Received: 10/22/2020 Patient Sequence Number: 1