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

Model Number CYF-V2R

Device Problem 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.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-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 Key: 6799363
• MDR Text Key: 82861208
• Report Number: 2951238-2017-00536
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• 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 Received: 08/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-V2R
• Device Catalogue Number: 2540635
• Device Lot Number: N/A
• Other Device ID Number: 04953170287619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Other