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

Model Number	GF-UE160-AL5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject scope was returned to the service center.The evaluation found the probe unit at the distal tip had a deep cut on the pink colored coating.Additionally, the ultrasound image had 12 broken elements and minor peeling of the adhesive on the distal end light guide lens and objective lens.The up/down control knob movement was loose and the angulations were below specifications.The scope was repaired to standard specifications and returned to the customer.A review of the scope's repair history shows the scope was last serviced via repair on (b)(6) 2018 due to probe damage and an image issue.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The service center was informed that the ultrasonic gastro-videoscope's cables were loose or broken.No patient injury or harm was reported.
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 (dhr) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the probable cause is likely external force was applied to the distal end.This issue is addressed in the instructions for use (ifu): "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.".

• 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: 11055305
• Report Number: 8010047-2020-10813
• Device Sequence Number: 2602568
• Product Code: ODG
• UDI-Device Identifier: 04953170355349
• UDI-Public: 04953170355349
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 01/26/2021

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: Other
• Device Model Number: GF-UE160-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 01/16/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1