MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number TJF-260V

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

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

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair of the subject device at olympus service operation repair center (sorc), it was found that the instrument channel was clogged with foreign material.The occurrence date of the event is unknown, and there was no report of patient injury associated with this event.

Manufacturer Narrative

The subject device was returned to sorc.Sorc checked the subject device and found the reported phenomenon.The exact cause has been under investigation.Therefore, 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.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was returned to olympus service operation repair center (sorc).Olympus medical systems corp.(omsc) reviewed the manufacturing 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 reported information from sorc, omsc surmised that there was possibility that the reported phenomenon was attributed to inappropriate or insufficient reprocessing by the user.If additional information is received, this report will be supplemented.

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the event occurred due to deformation of the forceps channel, breakage of the instrument, or foreign material in the forceps channel.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "operation manual.3.8 inspection of the endoscopic system.Inspection of the instrument channel and forceps elevator.Operation manual.Important information ¿ please read before use: precautions.Operation manual.3.6 inspection of ancillary equipment.Operation manual.4.3 using endotherapy accessories.Reprocessing manual.5 reprocessing the endoscope (and related reprocessing accessories).Reprocessing manual.7 reprocessing endoscopes and accessories using an aer/wd." olympus will continue to monitor the field performance of this device.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer's contact information and facility registration number.The facility registration number is 9610595.

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13137055
• MDR Text Key: 286959267
• Report Number: 8010047-2022-00791
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/07/2024

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: TJF-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 01/01/2022
• Supplement Dates Manufacturer Received: 01/17/2022; 12/26/2022; 05/07/2024
• Supplement Dates FDA Received: 02/11/2022; 01/04/2023; 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1