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

Model Number TJF-Q180V

Device Problem Mechanical Jam (2983)

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

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned to olympus for evaluation, upon inspection it was found kickback detected at k-wire and forceps elevator.In addition, guide wire tension test failed.It was noted the distal sheath adhesive was cracked, objective lens has small chips, the insertion tube was observed with minor buckling, angulation was low, also the control knob was loose.Additionally, the catheter movement was loose, and the guide wire did not function smoothly.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported to olympus the elevator is broken and it does not raise or lower on their evis exera ii duodenovideoscope.The issue was observed during reprocessing.The prior procedure was completed with no issues being noted.There were no reports of death, harm, or injuries related to this event.

Manufacturer Narrative

This report is being supplemented to provide the initial reporter's information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to the k-pipe was detached from the k-pipe stopper and movement of k-lever was not appropriately transferred to forceps elevator.It is also possible that due to metal fatigue from repeated stress, k-wire stopper was broken, and movement of k-lever was not appropriately transferred to forceps elevator.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13935151
• MDR Text Key: 297969354
• Report Number: 8010047-2022-05194
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170339967
• UDI-Public: 04953170339967
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2022

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-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/29/2022
• Supplement Dates Manufacturer Received: 03/28/2022; 06/22/2022
• Supplement Dates FDA Received: 04/26/2022; 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1