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 Unspecified Infection (1930)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

The scope was returned and was forwarded to an independent laboratory for microbial testing.As part of our investigation, an olympus endoscopy support specialist (ess) was requested to be dispatched to the user facility to observe the facilities reprocessing practice and to provide a reprocessing training.To date, the ess visit has not been finalized.If additional information becomes available, this report will be supplemented accordingly.This event has been reported by the importer on mdr # 2951238-2020-00427.

Event Description

The service center was informed of a reported patient infection as the infection prevention and control manager stated the facility was investigating two patients who acquired urinary tract infections and blood stream infections with the same organism post cysto procedure for stent removal.Different scopes were used for each procedure.The facility has observed the procedure in the clinic setting and did not observe any practice or infection control concerns.The scopes have been sent to the manufacturer's service center for evaluation of the scopes to ensure integrity.This is for 1 of 2 reports.

Manufacturer Narrative

The scope was sent to an independent laboratory for microbial testing.The scope tested negative.The scope will be ethylene oxide (eto) sterilized and returned to the service center for a physical evaluation.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

A visual inspection was performed on the received condition.The instrument channel was inspected and a dry white colored stain was noted inside the distal tip opening side.The objective lens and light guide lens at the distal end of the scope were inspected and there were no signs of foreign material or discoloration.The scope passed the leak test and the image met specifications.In addition, the service group the insertion tube was observed to have a minor curve.There are minor surface scratches noted on the insertion tube, light guide tube, video cable and connector.A review of the service history indicates the scope was purchased on (b)(6) 2019 and has received service via one repair on (b)(6) 2019 due to a failed leak test issue (cut/hole in the bending section cover).The repair was not related to any positive patient or scope cultures.Based on the investigations, the cause of the possible patient infection could not be conclusively determined.

Manufacturer Narrative

This supplemental report is being submitted to provide information provided from the endoscopy support specialist (ess).The ess reported the user facility has declined the reprocessing in-service at this time and the facility will contact the ess in the future if they decide to move forward.

• 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: 9975527
• MDR Text Key: 195577769
• Report Number: 8010047-2020-02257
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• 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: 01/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 50