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

Model Number	GF-UE160-AL5
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The referenced scope was returned to the service center for evaluation.The service group found the scope failed the water leak test due to a hole on the bending section cover.Additionally, the pink colored probe unit was chipped/missing piece (not exposing the core).The ultrasound connectors were found to have corrosion within.The scope was repaired and returned to the customer.As part of the investigation, olympus followed up with the customer to obtain additional information regarding the reported defect but with no results.A review of the scope's history shows the scope was last serviced via repair on (b)(6) 2019.The original equipment manufacturer (oem), performed a device history record review and no abnormalities were noted.No device was returned to the oem, however, an investigation was performed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The potential root cause has been determined to be due to external force was applied to the distal end.Olympus will continue to monitor the field performance of this device.To mitigate the risk of device damage, the instructions for use provides information that 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.
Event or Problem Description
The service center was informed that the ultrasonic gastro-video scope has a hole in it.It was unknown when the event occurred.No patient involvement was reported.

• 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: 10754987
• Report Number: 8010047-2020-08293
• Device Sequence Number: 13718470
• Product Code: ODG
• UDI-Device Identifier: 04953170203107
• UDI-Public: 04953170203107
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2020

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: 09/21/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1