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 device has not returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Olympus service operation repair center was informed that during preparation for use, it was found that the foreign matter adhering to around forceps elevator of the device (olympus loaner).Other detailed information was not provided.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device was returned to olympus service operation repair center (sorc).Sorc checked the device and found that there was the foreign matter and the dirt of the distal endo of the device.Omsc could not investigate the device, because the device was not returned to omsc.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Since the device was not returned, the exact cause was unknown.Based upon the information from sorc, there was the possibility that the reported phenomenon was attributed to the insufficient reprocessing of the device by the user.

• 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: 11402479
• MDR Text Key: 234538697
• Report Number: 8010047-2021-03220
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

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-UCT260
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 03/12/2021
• Supplement Dates FDA Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1