MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

Model Number LTF-S190-5

Device Problems No Display/Image (1183); Image Display Error/Artifact (1304); Communication or Transmission Problem (2896)

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

Event Date 08/23/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device has been returned to olympus for evaluation and the investigation is in process.The physical device evaluation has not yet been completed.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer reported the subject device displayed a b30 error code (scope communication error) and the image was not displayed.The reported issue occurred during a therapeutic pancreatic body and tail malignant tumor resection procedure.The intended procedure was completed using another device.There was no patient or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide information about the additional reportable malfunction found during device evaluation.During inspection and testing of the returned device, it was observed the device was displaying a noisy image, which is also a reportable malfunction.The reported issue (b30 error) was confirmed.In addition, service found there were scratches on the metal contacts.The adhesive between the objective lens and the curved part was cracked and chipped.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.

Manufacturer Narrative

Device manufacture date: nov 5, 2018 should have been selected on the initial report.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 event was unable to be identified; however, the event most likely occurred due to the following: 1) since there is a trace of water intrusion in the light guide connector, it is likely that this occurred as a result of temporary conduction failure caused by moisture that entered the scope.A) during cleaning and disinfection (including pre-cleaning), a load was accidentally applied in the water that caused the scope connector's vent valve to open.B) foreign objects such as pieces of cleaning equipment may have temporarily become caught in the valve of the vent metal, preventing the valve from closing.C) also, if liquid enters the air supply tube for water leakage detection due to submersion, the liquid may enter the inside of the endoscope during the water leakage test and cause damage to the endoscope.2) overcurrent occurred temporarily or repeatedly due to plugging and unplugging the video connector while the system was on.3) the image output signal was temporarily unstable due to the sudden application of static electricity or overcurrent.A) attaching or detaching with the system power on.B) overcurrent from other devices or electrical wiring.C) adhesion of dust or moisture to the electrical contact of the system and the video connector.Olympus will continue to monitor field performance for this device.

• Brand Name: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
• Type of Device: 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: 15586667
• MDR Text Key: 307021473
• Report Number: 9610595-2022-02035
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170310355
• UDI-Public: 04953170310355
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K201832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2022

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: LTF-S190-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 11/09/2022; 11/18/2022
• Supplement Dates FDA Received: 11/17/2022; 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2018
• 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
• Treatment: OTV-S190 VISERA ELITE VIDEO SYSTEM CENTER
• Patient Sex: Female