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

Model Number TJF-Q180V

Device Problems Device Reprocessing Problem (1091); Device Contamination with Chemical or Other Material (2944); Failure to Clean Adequately (4048)

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

Event Date 09/20/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegations were not confirmed.In addition to evaluation there was a pinhole on bending section cover causing water tightness to be lost.Objective lens was cracked.Adhesive on bending section cover was detached.Connecting tube was wrinkled.Scope cover was scratched.Grip was scratched.Forceps channel port was shaved.Switch button 1 was scratched.Switch box was scratched.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 coupled device unit was damaged causing, the image to have shadows and image to have roughness.Plastic distal end cover was scratched.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 evis exera ii duodenovideoscope experienced a leak from bending section cover and connector tube had wrinkles during reprocessing.During incoming inspection, the forceps elevator had foreign material.This mdr is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.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.The problem is likely due to a difference in recognition of device handling or reprocessing steps between olympus recommendation and the user facility.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.The instruction for use provides the following for reprocessing: ¿¿possibility that insufficient cleaning, disinfection or sterilization of device may pose an infection-control risk to the patients and operators who perform the following procedures using device.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.¿ reprocessing of subject device: the foreign material could not be identified.It is unknown whether the device was used on a patient with the foreign material attached.The customer follows correct reprocessing procedure based upon the instructions for use, however, the device could not be adequately reprocessed (including brushing) due to leakage from bending section cover.As confirmed by a field service engineer, at the customer¿s site although trained on cleaning/disinfect/sterilization steps, they tend not use air water channel cleaning adaptor and do not use maj-1888 for forceps elevator brushing.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: 15697189
• MDR Text Key: 306928769
• Report Number: 9610595-2022-03452
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2011
• 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