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

Model Number CYF-VHR

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The scope has not returned to olympus for evaluation.The reported complaint cannot be confirmed.Despite several followup attempts, no further information is currently available regarding the infection, the procedure involved, the patient outcome, the specific scope involved, its pre-procedure inspection, or whether the scope device is returning to olympus for evaluation.An olympus endoscopy support specialist has since provided retraining to address the reprocessing issues that were a potential contributing factor.If additional information becomes available, this report will be supplemented accordingly.

Event Description

1 of 3.During a customer education session on manual cleaning and disinfection, olympus was informed that the user facility had experienced a prior infection incident involving this model scope.The actual scope serial number was not disclosed.The infection type, date of procedure and patient details were not disclosed.It was reported that prior to the education session, the scope reprocessing at the user facility had not been performing the leak test, was not completing pre-cleaning, did not have the appropriate cleaning brushes for the endoscope channels, did not take the irrigation port off between uses, and did not completely immerse the endoscope in high level disinfection.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from nwb to faj.

• 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
• MDR Report Key: 8084684
• MDR Text Key: 127594316
• Report Number: 2951238-2018-00708
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310522
• UDI-Public: 04953170310522
• 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
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-VHR
• Device Catalogue Number: CYF-VHR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other