MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA ELITE DUODENOVIDEOSCOPE

Model Number TJF-Q290V

Device Problem Device Handling Problem (3265)

Patient Problem Injury (2348)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

The device in this report has not been returned to olympus medical systems corp.(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

The physician saw the forceps elevator raising by itself through the screen display even though the physician didn¿t operate the elevator control lever.They physician continued using the device and completed the intended procedure.The user found a v-shaped tissue remaining in the forceps elevator while reprocessing the endoscope.This tissue is likely to come from the patient body, but it is not sure exactly where the tissue came from.No additional treatment or another examination was required as of november 18.The user facility did not provide other detailed information.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) investigated the device.However, omsc could not confirm the device's malfunction.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.The exact cause of the reported event could not be conclusively determined.Omsc surmised that this phenomenon attributed to the following.-if suction was activated or the distal end of the endoscope was pushed against the mucous while removing the endoscope, mucous can be trapped in the gap and damaged by the edge of the distal end cover.-the user handling of the distal end cover attachment was inappropriate and the distal end cover was broken.Mucous can be damaged by the distal end cover.If significant additional information is received, this report will be supplemented.

• Brand Name: EVIS LUCERA ELITE DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11001294
• MDR Text Key: 223452311
• Report Number: 8010047-2020-10313
• Device Sequence Number: 1
• Product Code: FDT
• 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: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q290V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 06/04/2021
• Supplement Dates FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other