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

Model Number CYF-V2

Device Problem Device Reprocessing Problem (1091)

Patient Problem Urinary Tract Infection (2120)

Event Date 07/27/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has been received by olympus, but not yet evaluated.Awaiting permission from customer to culture the scope and ethylene oxide (eo) sterilize it before commencing with physical evaluation.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.The event has been reported by the importer on mdr# 2951238-2021-00388.

Event Description

It is reported by the customer "black pieces are coming out of solution" in connection with two cyf-v2 videoscopes.The customer further states patients have urinary tract infections.Additional details regarding the patient(s) and reported event(s) have been requested.At this time, no additional information has been provided.Case with patient (b)(6) reports one cyf-v2 scope.Case with patient (b)(6) reports one cyf-v2 scope.

Manufacturer Narrative

D9: device not received (b)(6) 2021-this is the date a loaner was shipped to the customer.The suspect device was not received by olympus.Olympus requested additional information four times from the customer with no response.For these reasons (no customer response and no device returned), permission could not be obtained to send the scope to a third party lab for culture testing, and physical inspection of the suspect device could not be conducted.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: instruction manual on cyf-v2 (reprocessing manual) has detailed instructions explaining proper re-processing methods.Following these instructions may have prevented the phenomenon to occur.Chapter 6 compatible reprocessing methods and chemical agents chapter 7 cleaning, disinfection, and sterilization procedures conclusions: the definitive root cause of the reported event could not be identified.Olympus was unable to establish the relationship between the subject device and the patient infection.The following describes the available information: ·unable to conduct culture test and physical device check.·precise data on each patient, microorganisms identified, date that the scope was used for patient examination, date that the infection was found, was not provided.

• 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 192-8 507; JA 192-8507
• MDR Report Key: 12379964
• MDR Text Key: 268735759
• Report Number: 8010047-2021-10877
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339431
• UDI-Public: 04953170339431
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other