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

Model Number	GF-UE160-AL5
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to an olympus service center for evaluation and the reported issue was confirmed.There was a deep cut on the pink rubber of the probe unit.In addition, there was an excessive scratch on the distal sheath, the cement was peeling on the light guide lens, there were four (4) broken elements on the ultrasound image, peeling on the ultrasound cord, and the control knob movement was loose.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The user facility reported to olympus that the distal tip rubber needed to be replaced on the ultrasonic gastrovideoscope.No patient harm reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the issue could not be conclusively specified.It was likely the issue was caused due to aging deterioration considering the date of manufacture of the device or to external force applied, e.G., rubbed excessively during daily use including reprocessing.The instructions for use (ifu) provides the following guidelines: inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, scratching, sagging, deformation, excessive bending, protruding objects or other irregularities.

• 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: 11769359
• Report Number: 8010047-2021-05810
• Device Sequence Number: 14397512
• Product Code: ODG
• UDI-Device Identifier: 04953170310546
• UDI-Public: 04953170310546
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: Health Professional
• Device Model Number: GF-UE160-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1