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

Model Number	GF-UE160-AL5
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The referenced ultrasound scope was returned to the service center for evaluation.The service group confirmed the balloon does not inflate as the probe unit leaks.The probe units was found to have sharp dents and the pink colored coating at the ultrasonic transducer of the probe was chipped / missing exposing the plastic underneath.Additionally, the insertion tube was kinked / buckled and there were ten broken elements on the ultrasound image.The unit was repaired and returned to the user facility.A review of the service records indicated the scope was purchased on (b)(6) 2012 with no previous repairs.The root cause cannot be determined at this time as the investigation is ongoing, however, if additional information becomes available this report will be supplemented accordingly.To mitigate damage to the ultrasonic probe, the instructions for use manual states, - inspect the ultrasonic transducer surface at the distal end of the endoscope¿s insertion tube for scratching, cracks, bulges, dents or other irregularities.- do not hold the ultrasonic transducer when holding the insertion tube.The ultrasonic transducer damage can result and/or the ultrasonic image will be abnormal.- do not remove the balloon with equipment such as forceps, needle holder, or hemostat that may scratch the surface of ultrasonic transducer.The ultrasonic transducer damage can result and/or the ultrasonic image will be abnormal.- do not wipe the ultrasonic transducer forcefully.The ultrasonic transducer damage can result and/or the ultrasonic image will be abnormal.
Event or Problem Description
The service center was informed that during a diagnostic procedure, the ultrasound gastrovideoscope was having balloon malfunctions as the balloon would not inflate.There was no patient injury reported.
Additional Manufacturer Narrative
This supplemental report was submitted to provide additional information to mdr# 8010047-2020-06019.The original equipment manufacturer (oem), omsc, performed a device history record review and no abnormalities were noted.No device was returned to the oem, however, an investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.Based on the investigation and the images provided, from the shape of the acoustic lens, the potential cause of the reported event can be attributed to the application of external force.At that time, it is assumed that the acoustic lens could not withstand the load and chipping occurred.To mitigate damage to the ultrasound scope, the instruction for use (ifu) manual states, - do not apply shock to the distal end of the insertion tube, particularly the ultrasonic transducer and the objective lens surface at the distal end.This could cause abnormalities in the visual and/or ultrasonic images.".
Additional Manufacturer Narrative
This supplemental report was submitted to provide the event date to mdr# 8010047-2020-06019.

• Brand Name: ULTRASONIC GASTROVIDEOSCOPE
• Common Device Name: ULTRASONIC GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10473318
• Report Number: 8010047-2020-06019
• Device Sequence Number: 19638037
• Product Code: ODG
• UDI-Device Identifier: 04953170355349
• UDI-Public: 04953170355349
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2020

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: No Information
• Device Model Number: GF-UE160-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 09/14/2020; 09/14/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 09/24/2020; 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1