MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT260

Device Problems Contamination /Decontamination Problem (2895); Failure to Clean Adequately (4048)

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

Event Date 11/11/2021

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed by the user that blood and fluids may have flowed back into the air/water channel during the endoscopy, and the device was also used in the next procedure at the doctor's discretion.The detailed information provided by the user was as follows.During the endoscopy, the air-feeding was insufficient, and when the device was confirmed after the endoscopy was completed, the air-feeding function did not work at all.The reported malfunction occurred in the second of the four procedures performed on (b)(6), 2021.Blood or fluid may have flowed back into the air/water channel during the second procedure.The user facility has only one ultrasound gastroscope gf-uct260.Although the user was concerned about the air-feeding function of the device, the doctor decided to use the device in two procedures performed after the second procedure.The air-feeding was also insufficient during the third and fourth procedures, but the doctor used the device to complete all four procedures.The device was used in combination with the video system center cv-260sl and the endoscopic ultrasound center eu-me1.The device had been reprocessed with a non-olympus automated endoscope reprocessor.There was no report of patient injury associated with the event.Based on the above, omsc determined that the endoscope that was improperly or insufficiently reprocessed was used in three procedures.A total of 3 reports are being submitted for this event.This is the second report.

Manufacturer Narrative

According to additional information provided by the malfunction information provider, the following was confirmed: -an olympus service representative connected the device to another light source and inspected it, and the air-feeding function worked without problems.-when the alternative gastroscope gf-uct260 was used in combination with the new air/water bulb maj-1444 and the light source used when the malfunction occurred, the air-feeding function was insufficient.-when the light source clv-290sl used at the time of malfunction and the biliary pancreatic endoscope were used in combination, the air-feeding function was insufficient.-no large amount of blood, including liquids or clots, came out of the device during device reprocessing.The device was evaluated at omsc.The evaluation is in progress currently.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.An olympus service representative visited the user facility and confirmed the following.-the contrast medium scattered during the procedure was attached to the connection part of the carbon dioxide gas tube of the co2 regulation unit, which is the air supply path.-the air supply was insufficient because the connection was loose due to the adhesion of contrast medium.The device was evaluated at olympus medical systems corp.(omsc).As a result of the evaluation, the following was confirmed.-there were no abnormalities in the parts that could be visually confirmed on the appearance of the device.-when the device was confirmed using the valve returned from the user facility, the air supply met the standard.-no evidence of blood and fluid regurgitation into the air/water channel was found.-the device was connected and operated according to the instruction manual, and there were no abnormalities.The device was sent to olympus service operation repair center (sorc) for repair after the investigation by omsc was completed.-the device was not watertight due to the perforations in the probe mount.-the insertion tube was scratched.-the forceps lever did not work smoothly.-the remote switches 1 and 3 were scratched.-the control section side of the universal cord was scratched.-the paint on the air/water cylinder was peeled off.The exact cause of the reported event could not be conclusively determined.Based on the information provided, since the connection part of the carbon dioxide gas tube was loose, there is a possibility that a phenomenon that air supply could not be performed at all occurred.Omsc confirmed from the device repair history that the control section grip, angulation and bending section rubber were replaced on november 2, 2021.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

• Brand Name: EVIS LUCERA 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: 12965943
• MDR Text Key: 286878527
• Report Number: 8010047-2021-15799
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• 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: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1