MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number JF-260V

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Event Description

An olympus field service engineer reported on behalf of the customer, the evis lucera duodenovideoscope experienced air/water leak from exhaust connector.The event occurred during preparation for use.The unspecified procedure was completed using another device.There was no report of patient harm associated with this event.During incoming inspection, it was determined there was foreign material inside of the light guide lens.This medwatch is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The subject device was returned to olympus for evaluation.In addition to the finds reported in event, angulation in the up direction was out of standards due to worn of angle-wire.The gap of up/down knob was out of standards due to worn of angle-wire.There were liquid leaks due to damage of channel pipe.There were liquid leaks due to deformation of right/left knob and up/down.There were liquid leaks due to deformation of forceps lever.The screen is partly dark due to charge coupled device being scratched.The charge coupled device lens was broken.There was a crease at the charge coupled device lens.The light guide lens was polluted.The adhesive part of bending section cover was broken.There was a pin hole switch button 1.The scope connector was deformed.The light guide cover glass was polluted.There was corrosion at the control part due to leakage.There was corrosion at the electrical connector due to leakage.The adhesive around charge coupled device lens was peeling off.The adhesive around light guide lens was peeling off.The light guide lens was broken.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

Additional information was provided regarding this event.There was no delay with unspecified diagnostic procedure.

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 a definitive root cause could not be established.However, it is likely that a) parts inside the light guide lens were corroded by moisture that ingresses the device from the leaking area.Corroded product was detected as foreign material.Or b) foreign material went inside the light guide lens from gap around the light guide lens that was made by physical stress to the distal end.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA 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: 15948847
• MDR Text Key: 308177380
• Report Number: 9610595-2022-05168
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JF-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2010
• 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