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

Model Number CYF-VH

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2020

Event Type  Malfunction  

Manufacturer Narrative

This report for non-fatal serious injury/device malfunction has been stored under the covid-19 pandemic in accordance with the guidance published by fda, postmarketing adverse event reporting for medical products and dietary supplements during a pandemic. Omsc reviewed the manufacturing history (dhr) of the device and confirmed no irregularity. The facility uses ecolab pureclean neutral detergent to manually clean the devices. They also use schulke thermosept detergent for automated endoscope reprocessing machine distributed by cantell. The devices were returned to olympus. Olympus tested them at a laboratory. The results reported that the devices tested negative for microorganisms and the black foreign materials derived from rubber, but not from microorganisms. The laboratory also reported that chemicals used for endoscope reprocess could produce the black substances. The devices were then returned to the customer after repair. After receiving a report that the event has recurred, the device was returned to olympus (b)(4) (oekg) again. Oekg sent the device to a third party laboratory for microbiological testing. As a result of the testing, no microbe was detected from the sample collected from the distal end and the suction, the instrument channels of the device. The testing result cleared the german guideline. Olympus performed on-site investigation and found that some components coming from rubber and copper were detected in the facility's sink used for the endoscope reprocessing. The exact cause of the reported event could not be conclusively determined. However, based on the information above, sterilizing the endoscopes with rubber and copper adhered to the distal end was likely to produce the black substances. In order to address the issue, the customer will check if no foreign materials adhere to the surface of the devices and make sure that the devices are completely dry. If additional information becomes available, this report will be supplemented.

Event Description

The customer repeatedly experienced that black foreign materials adhered to the distal end of their nine cyf-vhs. There was no report of infection associated with this report. A total of nine mdrs are being submitted for the nine endoscopes. This is the sixth one of the nine reports.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10646404
• MDR Text Key: 224676259
• Report Number: 8010047-2020-07351
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: UK
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 10/07/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CYF-VH
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 01/13/2015
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse