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

Model Number	GF-UCT180
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the service center for evaluation.The customer¿s complaint of ¿ the biopsy channel is blocked¿ was confirmed due to a foreign object being observed in the channel.The channel was also noted to scratched.The glue on the forceps cover was peeling and the bending section rubber glue was noted to be cracked.The scope id chip showed 168 total uses.No other anomalies were noted on the scope.An investigation is ongoing to obtain additional information regarding the reported event.If additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
The service center was informed that the biopsy channel is blocked and the forceps cannot be inserted or removed from the channel.There was no patient involvement reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the lm investigation.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The lm reports that the root cause could not be identified.The legal manufacturer provided the following possible cause for the reported event are presumed as follows: judging from the manufacturing year of the subject device, it is possible that the peeling was due to aging deterioration.Or, it is possible that the phenomenon occurred because an external force was applied to the subject device by strongly shaking it during re-processing or while it was normally used over a long period of times.The legal manufacturer checked the instruction manual and found the following description.Inspection of the endoscope: inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.As a result of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.

• 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: 11837916
• Report Number: 8010047-2021-06425
• Device Sequence Number: 2878665
• Product Code: ODG
• UDI-Device Identifier: 04953170355479
• UDI-Public: 04953170355479
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 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-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 05/17/2021
• 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