MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

As reported, after a second check the culture on the ultrasound endoscope 792336 is still positive with the presence of indicator organism.The number of cfu is greater than 20 and should not exceed 1 cfu during a second check for high-risk organisms.The device was placed in quarantine.The user then sent the device to the (b)(4) olympus subsidiary for hmi (hygiene microbiological investigation) for further investigation.The user did not report any contamination or any patient injury or patient infection to which this medical device could have been a contributory cause.No user injury reported.

Manufacturer Narrative

The customer culture results reported the device tested positive with the presence of indicator organism as provided below : culture test resulted at greater than 20 cfu/organisms.Klebsiella pneumoniae 21/22 cfu acinetobacter lactucae 23/24 cfu staphyloccocus epidermis 25 cfu (b)(4) olympus subsidiary for hmi (hygiene microbiological investigation) results obtained comply with the target level defined in the regulations of france outlined on july 4, 2016.The results are conform to french recommendation.Results: micro-organismes revivifiables 3 cfu gram positive bacteria detected coagulase negative staphylococci detected (b)(4) rrc will proceed with a normal repair if necessary.The customer cds checklist has not yet been received.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to g2.G2 - checked "other" to add the country belgium.Three attempts were performed to obtain the cleaning, disinfection, and sterilization of the scope instructions but were not successful.If additional information is obtained at a later date, a supplemental report will be submitted.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is unlikely the positive culture was caused by the device.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with instructions for use (ifu), the results conformed to the regulation's recommendation.This information is addressed in the instructions for use (ifu): "warning: thoroughly clean and high-level disinfect or sterilize the endoscope before returning it for repair.Improperly reprocessed equipment poses an infection control risk to each person who handles the endoscope within the hospital or at olympus." olympus will continue to monitor the field performance of this device.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• 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: 13014702
• MDR Text Key: 285802084
• Report Number: 8010047-2021-16201
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 06/13/2022
• Supplement Dates FDA Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1