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

Model Number GF-UCT260

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

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

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user facility that during the reprocessing of the subject device at user facility, while the brushing of the balloon channel, a black thread-like foreign material slightly appeared from the distal end.Then the balloon channel was flushed, the black thread-like foreign material came out from the balloon water suction port.The user facility stated that the procedure using the subject device before the reprocessing was completed without any problems, and the procedure was carried out without attaching a balloon.The detergent solution was aspirated through the suction channel and the balloon channel during the precleaning after the procedure.The facility already discarded the foreign material.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 olympus locations.Therefore, olympus could not investigate the subject device.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Based upon the information from the user facility, omsc presumed that the foreign material such as the patient's blood or tissue invaded into the subject device from the gap at the balloon water suction port or suction port, because the procedure at the user facility was performed without using a balloon.In addition, omsc presumed that the reported event was attributed to the following causes, which might be caused by the user.During the procedure, due to the pressure difference between the patient's body cavity and the subject device, the patient's blood and tissue flowed back into the subject device from the balloon water suction port.These materials solidified into the reported black thread-like foreign material.The foreign material such as dust invaded into the subject device from the suction cylinder before the reprocessing.If additional information is received, this report will be supplemented.

• Brand Name: EVIS LUCERA 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: 11377217
• MDR Text Key: 235012931
• Report Number: 8010047-2021-02997
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

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: Health Professional
• Device Model Number: GF-UCT260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1