MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. DUODENOFIBERSCOPE FOR ULTRASONIC SURVEY; ULTRASOUND GASTROVIDEOSCOPE

Model Number TGF-UC260J

Device Problem Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation, and the evaluation found that due to the deformation of the upward and downward angulation knob, water tightness was lost.Due to the wear of the angle wire, the bending angle in the up direction did not meet the standard value.Due to the wear of the angle wire, the play of the upward and downward angulation knob was out of the standard value.Due to the clogging of the air-water tube, no air and water was fed.Due to the clogging of the nozzle, the water removal ability did not meet the standard value.Due to nozzle clogging, the amount of water contact did not meet the standard value.The connecting tube and the image guide protector had a scratch.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported that the duodenofiberscope had air and water leakage from the body control unit.There were no reports of patient harm.During the device evaluation, the following reportable malfunction was found: the nozzle had foreign objects.This medical device report (mdr) is being submitted to capture the reportable malfunction found during the evaluation.

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, the observed foreign material in the nozzle could not be identified and a definitive root cause of the issue could not be determined, as there was no deformation that might result in the retention of foreign material and the facility device reprocessing was confirmed to have been implemented in accordance with the ifu, however, the issue was likely the result of insufficient device cleaning/reprocessing.The issue may be detected/prevented by following the instructions for use sections below: chapter 4 flow of reprocessing work for endoscopes and accessories chapter 5 reprocessing of endoscopes (and accessories that are reprocessed together) reprocessing survey info: - was the device cleaned, disinfected, and sterilized before being sent to olympus? - yes - was there a delay in the start of pre-cleaning? ¿ no - did the customer flush the air/water nozzle with water and air? - yes - were there any abnormalities in the accessories used for reprocessing? ¿ no - was the air/water nozzle wiped/brushed with clean lint free cloths, brushes, or sponges? ¿ yes - did the customer flush the air/water nozzle / channel with the detergent solution? - yes olympus will continue to monitor field performance for this device.

• Brand Name: DUODENOFIBERSCOPE FOR ULTRASONIC SURVEY
• 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: 18506192
• MDR Text Key: 333213969
• Report Number: 3002808148-2024-00432
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• 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: 12/21/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2016
• 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