MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DUODENOFIBERSCOPE FOR ULTRASONIC SURVEY; ULTRASOUND GASTROVIDEOSCOPE

Model Number TGF-UC260J

Device Problem Contamination (1120)

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

Event Type  malfunction  

Manufacturer Narrative

The device was sent in for evaluation and the customer¿s allegation of black liquid coming out from the tip was not reproduced.However, it was determined, the forceps channel had holes causing the leakage and the sticker part of the scoop connector seal was peeling off.In addition, it was noted, th probe water cover, the oscillator and the operation part were corroded due to water leakage.Also, scratches are found on the scope connector side of the universal cord and the play of the angle knob was out of the normal state due to the extension of the angle wire.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Event Description

An olympus representative reported to olympus, on behalf of the customer, the duodenofiberscope for ultrasonic survey had black liquid coming out from the tip and the forceps channel area.In addition, the scope connector seal was peeling.There were no reports of patient harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The investigation did not determine the cause of the hole in the forceps channel.A definitive root cause for the reported device problem was not established.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu), which state the following: ¿perform a leakage test on the endoscope after each precleaning procedure.Do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions.Use of a leaking endoscope may also pose an infection control risk.¿ olympus will continue to monitor field performance for this device.

• Brand Name: DUODENOFIBERSCOPE FOR ULTRASONIC SURVEY
• 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: 14717877
• MDR Text Key: 301860989
• Report Number: 8010047-2022-10196
• Device Sequence Number: 1
• Product Code: ITX
• 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,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TGF-UC260J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 06/27/2022
• Supplement Dates FDA Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2014
• 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