MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA PLEURA VIDEOSCOPE; FLEX DEFLECTABLE VIDEOSCOPE

Model Number	LTF-160
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inspection and testing, the reported issue (leakage from a-rubber) was confirmed and found to be caused by a cut on the a-rubber.The reported issue (damaged bending section) was not confirmed.However, it was observed the a-rubber was broken.In addition, service found there was leakage due to damaged instrument channel, deformed control unit, deformed switch box, and a cut on the universal cord.The objective lens was discolored, the distal end was shaved, the connection between the bending section and the connecting tube was not secured due to deformed bending tube, the adhesive on the a-rubber was detached, the bending tube was damaged, the grip was dirty, the bending angle in up direction was out of specification due to wear of the angulation wire, the forceps could not be inserted smoothly due to dented instrument channel, the return angle from bending of the bending section was out of specification due to damaged bending tube, all switch buttons were not working due to damaged switch box, and the light guide bundle was slipping down.The image was not displayed due to damaged ccd (charge-coupled device) unit and the image was noisy due to damaged ccd unit.The switch button #1 and the switch button #4 were damaged and not working.The investigation is ongoing; therefore, 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 or Problem Description
The customer reported the bending section was damaged and there was a leakage from the bending section cover (a-rubber) of the subject device.There was no patient or user injury reported due to the event.The subject device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, it was observed that the objective lens (ob lens) and the light guide lens (lg lens) had foreign objects.This report is being submitted for the malfunction found during device evaluation (ob lens and lg lens had foreign objects).Additional details have been requested regarding the reported issue.At this time, no additional information has been provided.
Additional 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 reprocessing of distal end was insufficient or, the reprocessing was not performed immediately after procedure, foreign material adhered to the distal end.The event can be prevented by following the instructions for use (ifu) which state: ifu (reprocessing manual) states as follows.1.3 precautions: failure to properly clean and sterilize endoscopic equipment after each examination can compromise patient safety.To minimize the risk of transmitting diseases from one patient to another, after each examination the endoscope must undergo thorough manual cleaning followed by sterilization.3.3 precleaning: if the endoscope is not immediately precleaned, residual organic debris will begin to solidify, and it may be difficult to effectively reprocess the endoscope.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Additional information was received from the user facility regarding the reported event (damaged bending section and leakage from a-rubber): the reported issue was observed while reprocessing the subject device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information that was received from the user facility regarding the reported issue.Updated fields: b3, b5, e1, e2, e3, and h6.

• Brand Name: EVIS EXERA PLEURA VIDEOSCOPE
• Common Device Name: FLEX DEFLECTABLE VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15513947
• Report Number: 9610595-2022-02419
• Device Sequence Number: 5920404
• Product Code: GCJ
• UDI-Device Identifier: 04953170340284
• UDI-Public: 04953170340284
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K013617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2023

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
• Operator of Device: Health Professional
• Device Model Number: LTF-160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 10/17/2022; 01/17/2023
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 11/08/2022; 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown