• 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-VHA
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
This supplemental report is being submitted to provide the device evaluation result. The device referenced in this report has been returned to olympus medical systems corp. For evaluation. During the evaluation, it was confirmed that there were scratches inside the wall of the instrument channel, there was a kink in the insertion tube near the boot, and there was foreign material attached on the universal code. It was also confirmed that the rubber cover around the instrument channel port was misaligned and a biopsy forceps was caught inside the instrument channel while inserting. The relationship between the confirmed results and the patient outcomes is unknown. This report is 11 of 17 reports.
 
Manufacturer Narrative
This supplemental report is submitting to correct "device product code".
 
Manufacturer Narrative
The device referenced in this report has not been returned to olympus medical systems corp. For evaluation. The manufacturing record of the subject device was reviewed with no irregularity. Since this spring, the newly appointed physician sometimes reportedly inserts a scope with excessive force during cystoscopy. Therefore, the user facility thought the handling might be the cause. The user facility considered the possibility that microorganism remained in the subject device, because the number of the patients who became prostatitis was large. The user facility reported that water sometimes dropped from the subject device due to insufficient drying as the subject device was put and stored on the table after reprocessing. Therefore, the subject device was reprocessed by aer (automated endoscope reprocessor) before use, but the reprocessing is not conducted recently. A service personnel from olympus checked the procedure of reprocessing at the user facility and the followings are noted. The user facility does not carry out disinfection in the water supply line of the aer. Forceps/irrigation plug is not disassembled during reprocessing. The aer displays e99. (this message is displayed on aer when the number of days after disinfectant replacement or the number of times of use is too many. ) the exact cause could not be conclusively determined at this moment, but it might be considered as a possible cause that there were some deviations from the instruction in reprocessing noted above. If additional and significant information becomes available, this report will be supplemented.
 
Event Description
Olympus was informed on (b)(6) 2017 that 6 outpatients having undergone cystoscopy with the subject device developed prostatitis. Furthermore, the number of the patients who developed prostatitis was added as follows. Additional 2 patients information was reported on (b)(6) 2017. Additional 1 patient information was reported on (b)(6) 2017. Additional 8 patients information was reported on (b)(6) 2017. Surveillance culturing tests were conducted for the subject device and an automated endoscope reprocessor by the user facility, but no microorganism was detected. Olympus obtained the following information on 6 out of 17 patients. This is 1 of 17 reports. Patient a: escherichia coli were detected from the patient. The user facility conducted cystoscopy for the male patient and the procedure was completed without irregularity on (b)(6) 2017. Symptoms of fever around 39 degree and urination pain appeared, and the patient was diagnosed as having prostatitis on (b)(6) 2017. The patient was not hospitalized, but an antibiotic was administered on (b)(6) 2017. The patient recovered on (b)(6) 2017. Patient b: the user facility conducted cystoscopy for the patient and the procedure was completed without irregularity on (b)(6) 2017. Symptoms of fever and urination pain appeared, and the patient was diagnosed as having prostatitis on (b)(6) 2017. Patient c: the user facility conducted cystoscopy for the patient and the procedure was completed without irregularity on (b)(6) 2017. Symptoms of fever and urination pain appeared, and the patient was diagnosed as having prostatitis on (b)(6) 2017. Patient d: the user facility conducted cystoscopy for the patient and the procedure was completed without irregularity on (b)(6) 2017. Symptoms of fever and urination pain appeared, and the patient was diagnosed as having prostatitis on (b)(6) 2017. Patient e: the user facility conducted cystoscopy for the patient and the procedure was completed without irregularity on (b)(6) 2017. Symptoms of fever and urination pain appeared, and the patient was diagnosed as having prostatitis. The date is unknown. Patient f: the user facility conducted cystoscopy for the patient and the procedure was completed without irregularity on (b)(6) 2017. Symptoms of fever and urination pain appeared, and the patient was diagnosed as having prostatitis. The date is unknown.
 
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
Manufacturer Contact
katsuaki morita
2951 ishikawa-cho
hachioji-shi, tokyo-to 
426425177
MDR Report Key6700118
MDR Text Key110249973
Report Number8010047-2017-00882
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCYF-VHA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2011
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: 07/11/2017 Patient Sequence Number: 1
-
-