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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-V2R
Device Problems Endoscope (802); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 07/18/2017
Event Type  Injury  
Manufacturer Narrative

As part of our investigation, olympus made multiple follow ups with the user facility by telephone and in writing in an attempt to gather additional information on the reported event; however, no additional information was obtained. The scope has not been returned to olympus for evaluation; however, upon performing an instrument service history review, it was discovered that the scope was last returned for evaluation and service on (b)(6) 2017 for a malfunctioning switch. In addition, an olympus endoscopy support specialist (ess) performed a reprocessing in-service training at the user facility on (b)(6) 2017. During the in-service, the ess found that the facility staff was hang-drying the scope with the irrigation plug still attached to the scope causing the irrigation plug to not dry properly. The ess demonstrated to the facility staff how to properly leak test the scope, reprocess and dry the irrigation plug, as well as high level disinfecting the scope. To add, the ess also provided a reprocessing wall chart to use for guidance. Based on the evaluation findings, the cause of the reported patient infections is likely attributed to insufficient maintenance / reprocessing of the scope. The instruction manual for use provides several warning statements in an effort to prevent cross contamination and patient infections. ¿failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each procedure may compromise patient safety. To minimize the risk of transmitting diseases from one patient to another, after each procedure the endoscope and its ancillary equipment must undergo thorough manual cleaning followed by high-level disinfection or sterilization. If the endoscope is not cleaned meticulously, effective disinfection or sterilization may not be possible. Be sure to perform a leakage test on the endoscope prior to manual cleaning. Do not use the endoscope if a leak is detected. Use of an endoscope with a leak poses an infection control risk to patients and operators and may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions. ¿ olympus will continue to investigate this report and if additional information becomes available, a supplemental report will be submitted.

 
Event Description

The user facility contacted olympus to request an on-site visit to assess their reprocessing practices, as there had been multiple patient infections reported during an unspecified period. Olympus was informed that the patients were examined with the subject scope. There was no specific information provided regarding the patients, and procedures. Olympus was further informed that some staff was not leak testing the scope, and was not high-level disinfecting the entire scope (only the insertion tube). The disinfectant solution used to manually reprocess the scope was an aldahol.

 
Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from nwb to faj and 510(k) number.

 
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Brand NameVISERA CYSTO-NEPHRO VIDEOSCOPE
Type of DeviceCYSTO-NEPHRO VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
408935-512
MDR Report Key6799363
MDR Text Key82861208
Report Number2951238-2017-00536
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation MEDICAL ASSISTANT
Type of Report Initial,Followup
Report Date 03/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-V2R
Device Catalogue Number2540635
Device LOT NumberN/A
OTHER Device ID Number04953170287619
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 Received02/13/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/16/2017 Patient Sequence Number: 1
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