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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-5
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Urinary Tract Infection (2120)
Event Type  Injury  
Manufacturer Narrative

The user facility did not provide a specific serial number for the device in question; therefore, it is unknown whether the subject device has been returned to olympus for service or not. Olympus contacted the user facility multiple times to obtain additional information regarding the reported event but to no avail. As part of our investigation into this report, olympus offered an on-site visit by an olympus endoscopy support specialist (ess) but the user facility declined the offer. No conclusion can be drawn at this time due to insufficient information provided by the user facility. This report will be supplemented when new information becomes available. This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes. A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

 
Event Description

The customer reported that two patients may have developed a urinary tract infection (uti) from the device and requested a copy of the reprocessing instructions for the subject device to ensure that they are reprocessing the scopes correctly. No further information provided. 1 of 2 reports, this is related to patient identifier# (b)(4).

 
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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 Key11036184
MDR Text Key222318714
Report Number8010047-2020-10654
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/28/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-5
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/22/2021
Was Device Evaluated By Manufacturer? No
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: 12/18/2020 Patient Sequence Number: 1
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