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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE Back to Search Results
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 4th of 5 reports.

 
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Brand NameOES CYSTONEPHROFIBERSCOPE
Type of DeviceCYSTONEPHROFIBERSCOPE
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 Key10716979
MDR Text Key213484740
Report Number8010047-2020-07993
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK032092
Number of Events Reported1
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 Received10/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-5A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/07/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/15/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/02/2018
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
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