MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number	TGF-UC180J
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the ultrasound gastrovideoscope had a damaged distal tip and the probe itself was chipped.The damage of the scope was seen during regular inspection of expired shelf life scopes.There were no reports of patient harm or injury.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.During device evaluation, it was found: the identification chip verified 33 uses, distal end plastic cover had scratches, bending section had fluid and was dry after aeration, button 1 had a hole, and forceps passage biopsy channel was leaking.The investigation is ongoing and follow up with the user facility has been performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional 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, phenomenon 1 "cracks on the probe unit" was reproduced.However, a probable cause could not be determined.The event can be detected/prevented by following the instructions for use which state: "do not coil the insertion tube or universal cord with a diameter of less than 12 cm.Equipment damage can result.Do not attempt to bend the endoscope¿s insertion section with excessive force.Otherwise, the insertion section may be damaged.Do not touch the electrical contacts inside the videoscope cable connector.Ccd damage may result.Do not apply shock to the distal end of the insertion section, particularly the ultrasound transducer and the objective lens surface at the distal end.Visual abnormalities may result.Do not pull or twist the ultrasound transducer at the distal end.Visual abnormalities may result.Do not hold the ultrasound transducer when holding the insertion tube.Ultrasound transducer damage can result and/or the ultrasound image will be abnormal.Do not twist or bend the bending section with your hands.Equipment damage may result.Do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks".Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Common Device Name: 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: 18415957
• Report Number: 3002808148-2023-14878
• Device Sequence Number: 8173862
• Product Code: ODG
• UDI-Device Identifier: 04953170328480
• UDI-Public: 04953170328480
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K093507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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
• Operator of Device: Health Professional
• Device Model Number: TGF-UC180J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown