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

Model Number TJF-150

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 09/12/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The forceps wire was completely cut off.In addition to the findings reported, the bending section adhesive was detached, scratches were found on the device, the auxiliary water inlet was deformed and the switch shaft of button 1 was detached, preventing it from being pressed down smoothly.Due the wear of the angle wire, the bending angle in down/right direction does not meet specification and due to the cut on the forceps wire, the forceps raising angle does not meet specification.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

The field service engineer (fse) reported on behalf of the customer, the forceps elevator on the duodenovideoscope was not working.During the inspection and testing of the returned device, debris was found on the forceps elevator.This mdr is being submitted to capture the reportable malfunction found during device evaluation.

Manufacturer Narrative

Updated fields: b3, b5, and h10.This report is being supplemented to provide additional information based on the device evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

Additional information was provided regarding this event.The event occurred during reprocessing.The identity of the foreign material is unknown.The device was not used on a patient with foreign material adhered.

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, it is likely that reprocessing steps recommended in the instructions for use was not completely conducted due to nonconformities of the device.As a result, foreign material remained on and around the forceps elevator.The event can be prevented by following the instructions for use which state: - "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: 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: 15621899
• MDR Text Key: 303720004
• Report Number: 9610595-2022-03022
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170229459
• UDI-Public: 04953170229459
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2012
• 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