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 09/22/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed.It was found, forceps elevator wire was damaged due to handling issues.In addition to evaluation in b5, the forceps elevator has foreign material, the adhesive on bending section cover was detached.Connecting tube was buckling.Protector of universal cord was damaged.The bending angle was reduced due to elongation of the angle wire.The play of the angulation knob was out of specification due to elongation of the angle wire.Charge couple device unit was damaged causing the image to have black dots.The plastic distal end cover was dented.Light guide lens was chipped.Adhesive around light guide lens was worn.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.

Event Description

An olympus field service engineer reported on behalf of the customer, the elevator up and down movement was not working on evis exera ii duodenovideoscope.During incoming inspection, the forceps elevator had foreign material.This mdr is being submitted to capture the reportable malfunction found during evaluation.

Event Description

Additional information was provided regarding this event.The event occurred during reprocessing, therefore, there was no patient involvement.The subject device was inspected prior to use.The identity of the foreign material is unknown.There is a possibility the device was used on a patient with foreign material adhered.However, no infection/impact on patient was reported.There was no delay in pre-cleaning of the device after the procedure.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported malfunction.The dhr confirmed that the subject device was shipped in accordance with the specifications.A definitive root cause for this issue was not established.The foreign materials could not be identified.There is no root cause of the material remaining in the device.It is probable the forceps elevator did not move due to forceps wire cut and therefore reprocessing steps were not conducted properly.As a result, the foreign material remained on forceps elevator.The instruction for use (reprocessing manual) provides the following: ¿all channels of the endoscope, including the elevator wire channel where fitted, must be cleaned and high-level disinfected or sterilized during every reprocessing cycle, even if the channels were not used during the previous patient procedure.Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection-control risk to the patient and/or operators performing the next procedure with the endoscope.¿ olympus will continue to monitor field performance for 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15697173
• MDR Text Key: 306813125
• Report Number: 9610595-2022-03453
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170367311
• UDI-Public: 04953170367311
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K143153
• 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
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

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: 10/03/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/29/2022
• Supplement Dates Manufacturer Received: 02/04/2023
• Supplement Dates FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2017
• 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