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 10/10/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation of image not displaying was confirmed due to corrosion inside the electrical connector.The allegation of low angulation was confirmed.The bending angle in up, down, left and right direction was insufficient due to the elongation of the angle wire.In addition to the finds reported in the event section, the nozzle was deformed.Adhesive on bending rubber cover was detached.The connecting tube was wrinkled.Scope cover was scratched.The grip was scratched.Forceps channel port was shaved.The universal cord was discolored and scratched.The scope connector was scratched.The light guide cover glass was corroded.The plastic distal end cover was dented.The switch button 1, switch box, right/left knob, up/down knob, forceps control lever, scope connector were dirty.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 low angulation and image not displaying.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

Updated fields: b3, b5, g2, h6 and h10.Correct field: h6 medical device problem code.Reprocessing of subject device: the subject device was inspected prior to use.The foreign material could not be identified by the customer.There is no possibility the device was used on a patient with foreign material.The customer is trained in reprocessing per the instructions for use.There is no delay of pre-cleaning.The customer also utilizes the brush during reprocessing.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 of the material remaining in the device could not be established.The foreign material could not be identified.Reprocessing manual provides the following: ¿if cleaning, disinfect, and sterilization of endoscope was insufficient, the device may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope.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.

Event Description

Additional information was provided regarding this event.The event occurred during preparation for use.The intended procedure was a therapeutic stent removal.

• 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: 15780294
• MDR Text Key: 307570103
• Report Number: 9610595-2022-03824
• 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: 03/22/2023

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: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2018
• 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