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

Model Number GF-UCT260

Device Problems Contamination (1120); Obstruction of Flow (2423); Physical Resistance/Sticking (4012); Failure to Clean Adequately (4048)

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

Event Date 10/23/2022

Event Type  malfunction  

Event Description

Customer returned the device for evaluation and repair of air/water flow being found insufficient during reprocessing.The previous unknown diagnostic procedure had been completed with this same device.There was no abnormality found with the device in inspection before use in that procedure.There is no patient involvement and no harm reported to any patient.Upon evaluation of the device, it was observed that the device nozzle had presence of foreign material that appears to be pale yellow tissue.The foreign material could be removed.The brush has resistance when entering the balloon channel.This medwatch is being submitted for the reportable issues of presence of foreign material and the resistance experienced in the balloon channel, as observed during device evaluation.

Manufacturer Narrative

This device is not sold in the u.S., but a similar device is.Information is provided for the reprocessing performed at the facility.A mh-946 injection tube is not used for manual cleaning at the facility.There are no scratches on the mounting part of the mh-946.The facility does not use automatic endoscopy reprocessors (aer).The nozzle of this device has not been changed before.The device is returned and an evaluation completed for it.Upon inspection and testing, it was observed that the device nozzle had presence of foreign material that appears to be pale yellow tissue.This was causing the reported issue of insufficient air/water flow.The foreign material could be removed.The brush has resistance when entering the balloon channel.Other observations for the device are: distal end cover (c-cover) is damaged; key top of ultrasonic probe is damaged; the light guide tube has leakage and is swelled; ultrasonic image is damaged; the distal end c-body and bending cover has leakage; insertion tube is wrinkled in many places; switches are worn; the scope cover (s-cover) is dirty; and objective lens is damaged.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to d8, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the nozzle clogged with light yellow tissue due to user misuse.However, a final root cause of this event was unable to be identified.Additionally, it¿s probable the resistance when inserting the brush into the balloon channel occurred due to the damaged plastic distal end cover.The root cause of the damaged plastic distal end cover was unable to be identified.The event can be prevented by following the instructions for use which state: ¿caution - to prevent clogging of the air/water nozzle, always use the air/water channel cleaning adapter to clean the air/water channel after each use.¿ olympus will continue to monitor field performance for this device.

• 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: 15812994
• MDR Text Key: 304112591
• Report Number: 3002808148-2022-04273
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• 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: 10/26/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2015
• 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