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 09/22/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed.The up/down knob was deformed causing water tightness to be lost.In addition to the finds reported, the control unit was deformed causing water tightness to be lost.Adhesive on bending section cover was detached.The connecting tube coating was peeling.The connecting tube was scratched.The switch box was dented.The universal cord was scratched.The bending angle in up, down, left and right direction was insufficient due to the elongation of the angle wire.The play of the angle knobs was out of specification due to the elongation of the angle wire.The nozzle was clogged causing water removal ability not to meet the specification.The nozzle was deformed causing water supply volume not to meet the specification.The plastic distal end cover was scratched.Inside of light guide lens was corroded.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 duodenovideoscoe experienced leakage from control knob.The event was found during reprocessing.There was no report of patient harm associated with this event.During inspection of the returned device, 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.Adhesion of foreign material to forceps elevator was confirmed.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.The problem is likely due to reprocessing steps recommended in instructions for use were not completely conducted due to nonconformities of the device.As a result, foreign material remained on the forceps elevator.The instructions for use (reprocessing manual) states: ¿¿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.The customer follows correct reprocessing procedure based upon the instructions for use without delay in precleaning, however, the device could not be adequately reprocessed (including brushing).The user facility stopped midway reprocessing due to leakage from the control knob.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: 15780397
• MDR Text Key: 307118112
• Report Number: 9610595-2022-03827
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• 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: 10/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2019
• 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