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.Inspection found the reported issue was not able to be duplicated.The device upon testing passed the dunk and cosmo test with no leak found.Further inspection found peeling on the forceps cover glue (control body) and crack on the ¿a-rubber¿ was noted.One broken element was observed on the um (ultra sound image) unit.Based on evaluation findings the reported issue was not able to be duplicated as the device was found no leak upon testing, however, physical defects were observed.The failure found could be attributed to use handling issue.This report will be supplemented accordingly following investigations.
Event or Problem Description
It was reported that leak at distal tip of the device was observed.The issue occurred during preparation for use.There was no patient involvement, no user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the peeling forceps glue cover was caused by an external force such as strong rubbing on the part in normal use or reprocessing.The following is included in the instructions for use which can detect the event: "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." per the legal manufacturer, a leak at distal tip of the device as included in the initial mdr has no potential to cause or contribute to death or serious injury if the malfunction was to recur.

• 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: 11848243
• Report Number: 8010047-2021-06493
• Device Sequence Number: 3224487
• Product Code: ODG
• UDI-Device Identifier: 04953170355479
• UDI-Public: 04953170355479
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 06/03/2021

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: 05/26/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1