MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number	GF-UCT180
Medical Device Problem Codes	Fluid/Blood Leak (1250); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user report was confirmed as the elevator channel plug was loose and leaking.Additionally, the light guide cover glue was peeling causing the probe unit to loosen.Glue was chipped on the c-cover affecting the insulation.The distal end was chipped.The ultrasound image had 3 broken strands.The insertion tube had multiple buckle points.The scope connector was corroded and had fluid invasion.The ultrasound connector as well as the us-el insulation also had fluid invasion.If additional information becomes available following device evaluation, a supplemental report will be filed.
Event or Problem Description
It was reported, the evis exera ii ultrasound gastrovideoscope would produce an image during procedure preparation.There was no patient harm or consequence reported as a result of this event.
Event or Problem Description
Corrected information: as reported by the user, the device had no image during preparation for use.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A review of the device history record (dhr), and a review of the instructions for use (ifu) were conducted during this investigation.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The ifu contains the following statements: ¿warning - do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.¿ as a result of the investigation and the condition of the device, it has been determined that the adhesive peel off due to external forces applied by rubbing strongly on the device.It is also possible that the adhesive deteriorated and peeled off due to long-term use.Olympus will continue to monitor the field performance of this device.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Common Device Name: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11607418
• Report Number: 8010047-2021-04510
• Device Sequence Number: 11737006
• Product Code: ODG
• UDI-Device Identifier: 04953170355479
• UDI-Public: 04953170355479
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K093395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1