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

Model Number GF-UCT180

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to any of the olympus locations.Therefore, olympus could not investigate the subject device.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user facility that during sampling for the microbiological test of the subject device by the user facility, it was found that there were some residues inside the instrument channel when aspirating through the instrument channel.Then, the user facility reprocessed the subject device and performed two microbiological tests.As a result of these tests, no microbe was detected each time from the sample collected from the instrument channel and the water channel of the device.There was no report of patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to any of the olympus locations.Therefore, olympus could not investigate the subject device.Olympus medical systems corp.(omsc) obtained the additional information that after the subject device had been used at another facility last time, it had been inspected and reprocessed by the service department of olympus and sent to the user facility which reported this event.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon (there were some residues inside the instrument channel) could not be conclusively determined.However, based upon the reported information, omsc surmised that this phenomenon was attributed to the following.- the service department or a user facility that used the subject device last time did not completely remove the blood or tissue of the last patient, so it remained as a foreign object.- foreign object such as dirt or dust invaded into inside the subject device after the subject device was shipped from the service department and before the subject device was inspected by the user facility.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: 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: 12180150
• MDR Text Key: 261911071
• Report Number: 8010047-2021-08953
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

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
• Device Operator: No Information
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/16/2021
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1