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  

Manufacturer Narrative

The customer culture results found a mixture of bacteria (unspecified type) in the device suction/work channel at >10 cfu.Microbiological test at (b)(4) reported no germs have been found on this instrument.All channels have been checked without finding any germs.The examination revealed test results passed in accordance with ¿rki-bfarm- guideline.Below are information on customers cds checklist: pre cleaning /bedside in examination room under 5 minutes , only water like mentioned in the manual.Brush used for instrument channel- bw-412t.Cleaning brush for the forceps- maj-1888.Accesorries/water bottle reprocessed- autoclave.Mediclean forte -the detergent used for cleaning.Pokayoke/pokayoke a and b- the detergent/disinfectant used for disinfection.Aer treatment type- getinge ew2.Scope storage- dying cabinet.Olympus service repair device physical evaluation were noted below: the acoustic lens were observed damaged.Impact point at the housing noted.Bending section was worn out and surface scratched and deformed on insertion tube was determined.Kinked on video connector was observed.The investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

It was reported that the device was tested positive several times (tip) with bacteria.It was noted that the damaged/open cementing of the "a- rubber" is the cause.The user then sent the device to third party 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

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, the relationship between the device and the culture-positive event cannot be determined.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "¦chapter 6 compatible reprocessing methods and chemical agents ¦chapter 7 cleaning, disinfection, and sterilization procedures" 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: 13015211
• MDR Text Key: 283667753
• Report Number: 8010047-2021-16224
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2012
• 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