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 customer¿s allegation was confirmed.In addition, the following non-reportable malfunctions were found during device evaluation: due to wear of angle wire, bending angle in up direction and the play of up/down knob does not meet specifications, control unit has corrosion due to water leakage, ultrasonic transducer has corrosion, and wrinkle and scratches found throughout the device.The investigation is ongoing.A supplemental report will be submitted upon the investigation's completion or if the user facility provides any additional information.

Event Description

The customer reported to olympus, that the duodenofiberscope for ultrasonic survey had a forceps channel pinhole.There was no report of patient harm or user injury associated with this event.During testing and inspection of the returned device, foreign matter came out of the channel (including secondary water supply) which had been attributed to insufficient cleaning.The device was cleaned, disinfected, and sterilized before it was sent in for repair.According to the customer, it is unknown when the foreign material adhered to the nozzle, there was no delay in the start of the pre-cleaning, the air/water nozzle was flushed with air and water, the nozzle was cleaned with lint-free cloths/brushes/sponges and the air/water nozzle was flushed with detergent solution.According to the customer no automatic cleaning with a cleaning machine due to channel pinholes.This medical device report (mdr) is being submitted to capture the reportable malfunction found during incoming inspection and 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, it is likely that the leak failure occurred due to channel pinhole, which the reprocessing could not be completed, and resulted in the residue of the foreign material.The event can be prevented by following the instructions for use: "chapter 3 compatible reprocessing methods and chemical agents chapter 4 reprocessing workflow for the endoscope and accessories chapter 5 reprocessing the endoscope (and related reprocessing accessories)" 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: 16729142
• MDR Text Key: 313654999
• Report Number: 3002808148-2023-03664
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• 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: 03/15/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2014
• 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