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 Type  malfunction  

Manufacturer Narrative

The subject device was not returned to omsc for evaluation but was returned to olympus service operation repair center (sorc).The evaluation is in progress currently.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 that during preparation for use, it was found that a black foreign material was clogged on the back side of the forceps elevator.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide the subject device evaluation result.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation but was returned to olympus service operation repair center (sorc).Sorc checked the subject device and found that the reported phenomenon could not be duplicated.Omsc reviewed the device history record (dhr) of the subject device and confirmed no irregularity.Based upon the information from sorc, omsc considered that the reported phenomenon was attributed to the insufficient reprocessing.

• 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: 11973841
• MDR Text Key: 280601902
• Report Number: 8010047-2021-07333
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: GF-UCT260
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1