• 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. OES CYSTONEPHROFIBERSCOPE

  • 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. OES CYSTONEPHROFIBERSCOPE Back to Search Results
Model Number CYF-5
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 08/27/2020
Event Type  Injury  
Manufacturer Narrative

The device was returned to olympus and evaluation is pending, as the device was sent to an off-site laboratory for microbiological testing. As part of our investigation into this report, an olympus endoscopy support specialist (ess) was dispatched to the user facility to assess the user facility¿s reprocessing practices, and provide reprocessing training if necessary. On november 13, 2020 an olympus ess visited the user facility to perform a scope reprocessing and infection control in-service for the staff. The ess covered infection control information referenced in the user manual and reprocessing manual. In addition, the ess requested the facility staff to show him each step in the use and reprocessing of the scope. Based on the ess' observation the facility staff was not currently using correct transport bins, not pre-cleaning, not leak-testing after each case, not currently reprocessing stopcock, not currently replacing saline bag or irrigation tubing between each case, not currently reprocessing reusable brushes, not currently soaking scope in detergent for the recommended amount of time, and not currently properly rinsing scope. The ess communicated these findings to the facility staff, and provided them a list recommended proper reprocessing techniques and proper handling and storage of the device. The ess recommended the use of disposable ancillary equipment and to consider using the gluteraldehyde based disinfectant, such as aldahol 1. 8. This report will be supplemented when new information becomes available.

 
Event Description

The attending physician reported that there were nine patients that were examined by the same cystoscope. After the procedure, the patients' urine samples were cultured and an esbl e. Coli had been recovered on those patients' urine sample. The patients were treated with antibiotic. The cystoscope was returned to olympus for evaluation to see if there had been any damage on the device. According to the physician, some of the patients have had urine retention, hematuria, septic issues, and uti after the procedures, which triggered him to have the patients' urine be cultured. In addition, it was reported that the device has been manually reprocessed and soaked in cidex opa (disinfectant). The user facility further reported that there had been no device culture performed prior to returning the device to olympus. This is for patient #9 and this is 9 of 9 reports. Cross-reference related reports: (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10934641
MDR Text Key219984585
Report Number8010047-2020-09729
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,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/02/2020
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? Device Returned To Manufacturer
Date Returned to Manufacturer08/31/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/04/2020
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: 12/02/2020 Patient Sequence Number: 1
-
-