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

Model Number TJF-160VR

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

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

Event Date 06/01/2022

Event Type  malfunction  

Manufacturer Narrative

The olympus fst was on site at the facility and repaired the device.An endocheck was performed, opened/closed control part, replaced albaran cable and soldered/adjusted stopper, replaced necessary small parts and o-rings, and function tested/leak tested after repair.According to the fst, the defect could have resulted in an injury to the mucous membrane.The spliced albaran cable was a known phenomenon, due to design.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.A supplemental report will be submitted upon completion of the investigation.

Event Description

The olympus representative reported the albaran bowden cable spliced on the evis exera duodenovideoscope.The issue was detected by the field service technician (fst) during inspection service.The user was not aware of the problem.No patient harm reported.During the evaluation of the device, it was noted some of the wires that compose the forceps elevator wire were raised due to cut or fray.This report is to capture the reportable malfunction of some of the wires that compose the forceps elevator wire were raised due to cut or fray noted at estimation.

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.It has been over 14 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to a defective wire (designated as the "k-wire").It was not possible to determine or surmise further the cause of the defect.Users can detect the event in accordance with the following instructions for use (ifu): "be sure to prepare another endoscope to avoid that the examination will be interrupted due to equipment failure or malfunction." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA 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: 14885119
• MDR Text Key: 303669941
• Report Number: 8010047-2022-11169
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K024033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-160VR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2008
• 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