MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC GASTROVIDEOSCOPE

Model Number	GF-UCT140-AL5
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation and the investigation is ongoing.The physical device evaluation has not been completed.Prior to the device evaluation, the device was sent out for additional cultural testing.The microbiological analysis results are pending.The customer provided the cleaning, disinfection, and sterilization process stating the pre-cleaning detergent is olympus.The air/water channel, auxiliary water channel, balloon channel, and forceps elevator wire channel were aspirated and flushed with water.The manual detergent is olympus and no manual disinfectant is used.The instrument/suction channel, suction cylinder, instrument channel port, balloon channel, and distal end were brushed.The storage practice is hanging the scopes vertically, and desconocida is the maintenance company.The cleaning, disinfection, and sterilization (cds) was performed by the customer.There was no patient infection.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
The customer reported to olympus, during reprocessing, the ultrasonic gastrovideoscope tested positive for over 10,000 colony forming units (cfus) of enterobacter cloacae.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
Additional Manufacturer Narrative
Please see d4 and e1 for further information.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.Based on the results of the investigation, a root cause could not be determined.The instruction manual of gf-uct140-al5 describes the reprocessing methods in the following chapters: chapter "compatible reprocessing methods and chemical agents" chapter "cleaning, disinfection, and sterilization procedures" olympus will continue to monitor field performance for this device.

• Brand Name: ULTRASONIC GASTROVIDEOSCOPE
• Common Device Name: ULTRASONIC GASTROVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15686664
• Report Number: 3002808148-2022-03626
• Device Sequence Number: 15278928
• Product Code: ODG
• UDI-Device Identifier: 04953170062797
• UDI-Public: 04953170062797
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K012080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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
• Operator of Device: Health Professional
• Device Model Number: GF-UCT140-AL5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown