MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CORP. LTD. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

Device Problems Fluid/Blood Leak (1250); Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/08/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was able to be confirmed.During the device evaluation it was observed that the reported issue was due to a leak in the biopsy channel causing corrosion in the body control unit.It was also observed that the scope connector had fluid and corrosion after aeration.It was observed that there was multiple broken ultrasonic images.Also, it was observed that the glue of the bending section cover was cracked.It was observed that the ultrasonic electrical insulation did not meet the standard.Lastly, minor scratches were observed on the distal end of the device.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus the evis exera ii ultrasound gastrovideoscope had foreign material exiting from the biopsy and auxiliary water channel.After reprocessing in the oer pro, the scope was hung in a cabinet, and it was observed that black water was pouring out of the end of the scope.The reported issue occurred during testing and reprocessing of the unit.There was no patient/user harm or injury reported due to the event.

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.The device met all specifications at the time of shipment.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, the specific root cause of the foreign material exiting from the biopsy and auxiliary water channel could not be determined at this time.The following information is stated in the instructions for use (ifu) which may have prevented the event: "caution after using the endoscope reprocess it according to the instructions given in chapter 7, ¿cleaning, disinfection, and sterilization procedures¿.Using improperly or incompletely reprocessed, the endoscope¿s distal end damage may result.Chapter 7 cleaning, disinfection, and sterilization procedures warning: all channels of the endoscope, including the elevator wire channel and balloon channel, must be cleaned and high-level disinfected or sterilized during every reprocessing cycle, even if the channels were not used during the previous patient procedure.Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CORP. 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: 15553788
• MDR Text Key: 306901919
• Report Number: 3002808148-2022-02861
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170341809
• UDI-Public: 04953170341809
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• 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: 09/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2015
• 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