MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT260

Device Problems Device Reprocessing Problem (1091); Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/22/2023

Event Type  malfunction  

Event Description

An olympus employee reported on behalf of a customer, when medical staff took out the evis lucera ultrasound gastrovideoscope from storage, they noticed there was blood around the forceps elevator.The device was cleaned and disinfected again, and after the pre-use inspection, it was used during another case.There was no health hazard to the patient.After use in the fluoroscopy room, it was cleaned and disinfected, but the cleaning staff said that bedside cleaning may not have been performed.There is a possibility that the forceps elevator was washed without raising during washing.An olympus service representative witnessed reprocessing on (b)(6) 2023 and (b)(6) 2023.Regarding the inspection immediately after use (air supply and water supply to the air/water balloon was conducted using maj-1444), no one performing reprocessing at that time was pursued, but one out of three water supply was carried out with off.There was no problem with the water supply of the air/water channel cleaning adapter.It was recognized that water was being delivered when the air supply was off.A visual check of the endoscope tip was not performed.A fact-finding survey was conducted on (b)(6), and warnings were issued to staff who were following incorrect procedures.A reprocessing study session for bedside cleaning and brushing was held from (b)(6).

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was not confirmed.The forceps elevator was raised and lowered, but there was no confirmation of blood adhesion.The customer was able to clean, disinfect and sterilize the subject device prior to sending it to olympus.There were no abnormalities with the following: bending mechanism, endoscopic image, ultrasound images, remote switch, or combination with related equipment (eu-me2pp, cv-290, clv-290sl).The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

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.Based on the results of the investigation, it is likely that the phenomenon occurred due to a lack of cleaning of the equipment due to a deviation in the facility's reprocessing procedure.The event can be prevented by following the instructions for use: "chapter 6 application and conditions of cleaning, disinfection and sterilization chapter 7 cleaning, disinfection and sterilization procedures" olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information that was received about the event.It is possible that the forceps had been washed without raising the upper table of the forceps during washing.There were cases in which water insufflation was carried out with the insufflation turned off.There was no issue with water delivery of the air and water channel cleaning adapter.The endoscope tip was not visually checked.The issue was presumed to be caused by a lack of cleaning rather than a defect on the button side.

• Brand Name: EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16592288
• MDR Text Key: 312302703
• Report Number: 3002808148-2023-02833
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UCT260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2014
• 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
• Treatment: MAJ-1444.