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

Model Number	GF-UCT180
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was evaluated by olympus and it was noted that the light guide cover glue at the distal end was peeling, attributable to a shock caused by dropping and knocking the endoscope to a hard surface or object (handling issue).The device was repaired and returned to the customer.
Event or Problem Description
A user facility returned a device for repair due to a reported hole in the ultrasound tip.Upon evaluation of the returned device, it was noted that the light guide cover glue at the distal end was peeling.There was no patient injury or harm, associated with the problem, reported to olympus.
Additional Manufacturer Narrative
This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation.Updates to sections h4 and h6.The device history record for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause was not identified.The investigation determined the likely cause of the peeling of the light guide cover glue at the distal end was user handling.As stated in the instructions for use, as a preventive measure, "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.".

• 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: 11489991
• Report Number: 8010047-2021-03727
• Device Sequence Number: 5211534
• Product Code: ODG
• UDI-Device Identifier: 04953170355462
• UDI-Public: 04953170355462
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

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: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1