MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GASTROVIDEOSCOPE

Model Number GF-UE160-AL5

Device Problem Fluid/Blood Leak (1250)

Patient Problem Aspiration/Inhalation (1725)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has been received by olympus, but has not yet been evaluated.The definitive cause of the customer's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the evaluation or upon receipt of additional relevant information.

Event Description

It is reported during an esophagogastroduodenoscopy (egd) with ultrasound and colonoscopy using an ultrasonic gastrovideoscope, fluid filled the patient's lungs.This fluid was suctioned out.The procedure was completed using a different scope.The patient required extra oxygen, extra time in the pacu, and was kept overnight in the hospital for observation due to this occurrence.The patient was discharged the next day in good condition.

Manufacturer Narrative

This report is being updated to provide investigation findings.Physical evaluation of the complaint device reveals: the plastic distal end cover has minor scratches.The user's reported issue of device leak could not be replicated.The video scope was leak tested using two methods; one method consisted of the water dunk test, and the other consisted of the cosmo leak test.During the water dunk test, the scope was connected to the airline and submerged underwater for a total of 6 minutes, with no signs of leakage.Additionally, the video scope was connected to the cosmo leak test machine, and the results on the machine indicate that the device had passed (no leak).The test valves were able to connect securely to their designated areas on the scope, with no signs of becoming loose.The video scope was then connected to the processor, and the air button was activated on the light source.The air/water valve was fully actuated, and olympus verified fluid emitting from the distal end.At this point, the air/water valve was partially depressed to activate the air function.There was no post drip noted at the distal end of the scope after using the air.The suction system also functioned.The device history record (dhr) for the complaint device has been evaluated.All records indicate that the product was manufactured, tested in accordance with all applicable procedures, and met all final product release criteria.The instructions for use (ifu) shipped with the device provides the user with the following information related to the reported event: chapter 3 preparation and inspection warning using a valve that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.Conclusion: the definitive cause of the user's reported event cannot be established.The customer states that a leak in the device during procedure on facility caused a health hazard to the patient.However, the inspection results of the device could not duplicate a leak in the device when tested.In addition, it has been confirmed that the functions of ventilation water and suction are also normal when combining with the said device using maj-1443/maj-1444 for inspection.Based on the information above and the information at the time of the occurrence of the phenomenon, it is highly likely that this phenomenon occurred due to maj-1444 of the ventilation water button.The possible factors are as follows.Maj-1444 was not installed correctly.Maj-1444 packing was damaged due to some reason, leading to a water leak.Damage or deformation due to deterioration or wear of parts, etc.Functional loss due to stack of internal parts.Based on the investigation findings is likely the reported phenomenon occurred due to handling of the device.The reported issue it is detectable during the inspection before the use of the equipment.

Manufacturer Narrative

H6 codes heath effect - impact code - code "4607" added as it was inadvertently not included on the previous submission.Investigation findings - codes corrected from previous submission.Investigation conclusions - codes corrected from previous submission.

• Brand Name: ULTRASONIC GASTROVIDEOSCOPE
• Type of Device: ULTRASONIC 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: 11147968
• MDR Text Key: 258643286
• Report Number: 8010047-2021-01172
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356261
• UDI-Public: 04953170356261
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UE160-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2020
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 100 KG