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

Model Number GF-UE160-AL5

Device Problem Poor Quality Image (1408)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.During the evaluation, the pink rubber was found with a deep cut.The image was visible after aeration and the ultrasound image contained one broken element.All the camera switches and the scope connectors were working properly after aeration.The control knob was found with low tensions.No other issues were found during the device inspection.If additional information is obtained a supplemental report will be filed.

Event Description

A user facility reported image issues on a gastrovideoscope.No patient involvement or injury was reported.No additional information has been obtained.

Manufacturer Narrative

The investigation has been completed.A device history record (dhr) review was performed and found no non-conformances that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.The instructions for use (ifu) 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.¿ the root cause could not be conclusively determined.Probable causes that could have led to the reported event include that the water immersion in the interior may have led to the occurrence of this phenomenon.In addition of an external force might have been applied to the distal end of the acoustic lens because the image showed that the acoustic lens was damaged, and there was also a lack of sound line.

• Brand Name: ULTRASONIC GASTROVIDEOSCOPE
• Type of Device: 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: 10900770
• MDR Text Key: 218224259
• Report Number: 8010047-2020-09423
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• PMA/PMN Number: K051541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UE160-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1