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

Model Number TJF-260V

Device Problem Mechanical Problem (1384)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The subject device 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 is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that in unspecified timing the forceps elevator remained been raised.Olympus service operation repair center (sorc) checked the subject device and found that the reported phenomenon could not duplicated.There was no patient injury associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacture history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the information from olympus service operation repair center (sorc), there was the possibility that the reported phenomenon was attributed to a foreign matter got stuck in the forceps elevator, an external factor, or user handling.

Manufacturer Narrative

This supplemental report is being submitted to provide correction of ¿d9¿, ¿h3¿, ¿h6¿ and ¿h10¿ in the initial report and the follow-up number 1 report (the correct answer is please see each item of this report).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.Based upon the information from sorc, omsc considered that the reported phenomenon was attributed to temporary pinching of foreign materials due to external factors or handling.

• Brand Name: EVIS LUCERA 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: 11010706
• MDR Text Key: 221558918
• Report Number: 8010047-2020-10379
• 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: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2021

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: TJF-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 01/07/2021; 05/10/2021
• Supplement Dates FDA Received: 01/14/2021; 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1