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

Model Number CYF-VH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 08/18/2019

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned for evaluation.If additional information becomes available following device evaluation, a supplemental report will be forwarded the agency.

Event Description

It was reported that the manufacturer was informed that two(2) patients may have acquired an organism linked to a urology procedure using a olympus cystoscope.The microorganism was salmonella enterica.The customer stated on examination of this specific scope, they were concerned about the lack of integrity on the surface of the scope.Complaint 2 of the 2.

Manufacturer Narrative

The scope was sent to an independent laboratory for microbial testing.The summary of the test results indicates the reported salmonella enterica was not identified as the scope's instrument/suction channel tested negative.The scope will be ethylene oxide (eto) sterilized and returned to the service center for a physical evaluation.If a additional information becomes available, this report will be updated accordingly.

Manufacturer Narrative

The manager of infection prevention further reported that the patient was identified to have a urinary tract infection.This scope had been quarantined.The cystoscope was leak tested, brushed using channel cleaning (bw412t), air flushed after the manual cleaning and then sterilized.There were no issues noted related to any reprocessing equipment regarding errors, alarms, or smoke.A senior nurse consultant/educator previously conducted an in-service in repair reduction and reprocessing training on this scope previously on (b)(6) 2019.The senior nurse consultant/educator provided information and recommendations on the repair reduction ontrack checklist that has been designed to strengthen and build upon existing processes and practices and to support in achieving an efficient, quality driven service that meets best practice standards.A review of the service history for the scope indicated the scope was purchased on (b)(6) 2018 with service/repair records.

Manufacturer Narrative

The referenced scope was returned to the service center for a physical evaluation.A visual inspection was performed on the received condition of the scope.A thin diameter borescope was utilized to inspect the inside of the instrument channel and there were no signs of tear marks, discoloration, or foreign objects inside the instrument channel.The scope passed the leak test.The image was checked and the image is normal.Additionally, the insertion tube was inspected and noted a small dent on the outer tube near the logo.Based on the evaluation the cause of the reported event could not be confirmed as there was no evidence of foreign material or foreign object inside the channel.

• Brand Name: 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: 9234921
• MDR Text Key: 170793849
• Report Number: 8010047-2019-03696
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411250
• UDI-Public: 04953170411250
• Combination Product (y/n): N
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 11/05/2019; 03/17/2020; 04/12/2020
• Supplement Dates FDA Received: 02/21/2020; 03/17/2020; 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other