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

Model Number TJF-Q180V

Device Problems Device Contamination with Chemical or Other Material (2944); Failure to Clean Adequately (4048)

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

Event Date 01/16/2023

Event Type  malfunction  

Event Description

A customer reported to olympus, the evis exera ii duodenovideoscope light out was very low.The light became darker and darer during the examination.There was no report of patient harm associated with this event.During incoming inspection, it was determined foreign material was found at forceps elevator.This medwatch is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed.Due to dirt on light guide lens, illumination was uneven.Due to breakage of light guide bundle, illumination was poor.In addition to evaluation in event, forceps channel port had a dent.Suction cylinder had discoloration.Switch box had a dent.Due to wear of angle wire, bending angle in right direction did not meet the standard value.Due to damage on forceps wire, fixing force of guide wire did not meet the standard value.Connecting tube had a wrinkle.Connecting tube had a scratch.Adhesive around objective lens had wear.Light guide lens was dirty.There was corrosion around forceps elevator.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 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, regarding the foreign material adhered to forceps elevator: it is likely that a foreign material may not have been removed because reprocessing could not be performed properly due to malfunction of the forceps elevator caused by damage on the wire.Regarding the inside of the lens was dirty: it is likely that the lens glue peeled due to physical stress such as hitting or dropping the distal end, chemical stress due to chemical solutions used, or similar.Then humidity may have been allowed to go inside the lens and caused corrosion.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "the detection method is contained in evis exera ii tjf type q180v operation manual chapter 3 preparation and inspection.The preventive measures are contained in evis exera ii tjf type q180v reprocessing manual 5.4 manually cleaning the endoscope and accessories." olympus will continue to monitor the field performance of this device.

• Brand Name: EVIS EXERA II 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: 16383098
• MDR Text Key: 309639103
• Report Number: 9610595-2023-02600
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170367311
• UDI-Public: 04953170367311
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

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
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 04/25/2023
• Supplement Dates FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2011
• 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