MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. 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 Type  malfunction  

Manufacturer Narrative

The device was returned as part of the asset return process and other findings includes: the nozzle is shaved; the adhesive on the bending section cover is detached; the connecting tube has a buckling; the light guide cover glass has stain; the control unit is deformed; the switch box has a scratch; the universal cord has a scratch; the suction connector has corrosion due to water leakage; the electrical connector has corrosion due to water leakage; due to wear of angle wire, the bending angle in an up/down/right/left direction does not meet the standard value; due to wear of angle wire, the play of the up/down (right/left) knob is out of the standard value; due to fray of knob wire, the forceps raising angle does not meet the standard value.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

A user facility returned the olympus asset, duodenovideoscope, to the olympus service center.Upon inspection and testing of the returned device, it was observed that the knob wire was found damaged.Some of the wire that composes the forceps elevator wire was raised due to a cut or fray.This report is being submitted for the reportable malfunction found during evaluation.There was no patient involvement.

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 13 years since the subject device was manufactured.Based on the results of the investigation, the knob wire may have been damaged by repeated manipulation of the forceps elevator, the distal cover may have caught on the broken knob wire when the cover was attached, or the broken knob wire contacted a cleaning brush while brushing the distal end.However, specific root cause could not be determined.The event can be detected/prevented by following the instructions for use: the tjf-160vr operation manual provides detailed instructions for the device inspection in chapter 3, section 2.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18553399
• MDR Text Key: 333455211
• Report Number: 9610595-2024-01332
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2010
• 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