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

Model Number	GF-UE160-AL5
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the service center for evaluation.A leak was noted on the bending section rubber glue was found damaged.There were deep cut/holes on the pink rubber of the probe and bending section rubber.There were four broken elements in the ultrasound image.The scope¿s angulation was checked and found to be abnormal.There was low tension and loose play were noted with the function of the scope¿s control knob.The gf-ue160-al5 instruction manual provides the following statements to prevent scope damage.Do not twist or bend the bending section with your hands.Equipment damage may result.Do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.
Event or Problem Description
The service center was informed that during reprocessing , the scope failed the leak test due to a hole in the distal tip rubber.There was no patient involvement reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on legal manufacturer's final investigation.Based on the legal manufacturer's investigation, the dhr was reviewed and there was no problem found during the manufacturing of the device.In addition, "the dhr confirmation result, it was confirmed that there was no flaw of the acoustic lens and leakage of the a rubber adhesion part at the time of shipment.To date, the legal manufacturer cannot conclusively determined the cause of the reported phenomenon; however, physical damage or exerting an excessive force to the distal end cannot be ruled out as a contributory factor.

• 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: 10857651
• Report Number: 8010047-2020-09049
• Device Sequence Number: 2962591
• Product Code: ODG
• UDI-Device Identifier: 04953170203107
• UDI-Public: 04953170203107
• 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: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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: Health Professional
• Device Model Number: GF-UE160-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1