• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-VHR
Device Problem Device Reprocessing Problem (1091)
Patient Problems Bacterial Infection (1735); Unspecified Kidney or Urinary Problem (4503)
Event Date 04/08/2021
Event Type  Injury  
Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation. The definitive cause of the user's experience cannot be determined at this time. The investigation is ongoing. This report will be updated upon completion of the investigation or upon receipt of additional relevant information. This event has been reported by the importer on mdr# 2951238-2021-00345.
 
Event Description
It is reported during a cystoscopy procedure using a cysto-nephro videoscope, at the end of the procedure, a black speck was noted to be floating in the patient's bladder. The physician believes he removed the speck from the bladder with a syringe. The scope was removed, and when wiping the scope, black residual/specks were noted on the 4x4 gauze by the surgical technician (st). The st had inspected the scope prior to the procedure for residual/specks and none was found. The patient was made aware of the speck found in the bladder. The physician ordered amoxicillin 500mg by mouth for one dose. No further consequences to the patient have been reported. Additional details have been requested regarding the patient and reported event. At this time, no additional information has been provided.
 
Manufacturer Narrative
This report is being updated to report additional information and corrected information.
 
Event Description
Additional information: in mw5101053, this facility reports 6 cases. (b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCYSTO-NEPHRO VIDEOSCOPE
Type of DeviceCYSTO-NEPHRO VIDEOSCOPE
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 Key11939845
MDR Text Key254334415
Report Number8010047-2021-07110
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCYF-VHR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2020
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: 06/04/2021 Patient Sequence Number: 1
-
-