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 Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation of reduced angulation was not confirmed.In addition to evaluation in report adhesive on bending section cover was detached.Bending section cover was dirty.Due to wear of angle wire, the play of up/down and right/left knob was out of the standard value.Plastic distal end cover had a dent.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 duodenovideoscope had reduced angles in all direction during reprocessing.There was no report of patient harm associate with this event.During incoming inspection, it was determined the forceps elevator had foreign material.The foreign material was yellowish/brown in color, but it is unknown what the material is.This medwatch 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 legal manufacturer's final investigation and good faith efforts.The e1 "telephone number," e2/e3 and g2 fields were corrected based on information available at the initial report submission.The following additional information was obtained with regards to the customer's reprocessing steps: there was no reprocessing done after last procedure.However, in general customer follows correct reprocessing as per olympus training and instructions for use.The device could not be reprocessed (including brushing) and stopped midway due to the issues in it.Device was not completely reprocessed at the time of pickup of device for inspection.The user inspected the device for abnormalities prior to use, no issues were found.The scope was not used on a patient with foreign matter.The customer follows reprocessing per training and instructions for use, however due to patient load the brushing is done fast and does not look very efficient.The manual cleaning is performed within an hour after the procedure but sometimes is delayed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the subject device was manufactured.Based on the results of the investigation, the device was sent to olympus without being reprocessed completely at the user facility.As a result, foreign material was left in the forceps elevator and the subject device.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: detection way is included in tjf type 150 operation manual chapter 3 preparation and inspection.Preventive measures are included in tjf type 150 reprocessing manual 3.5 manual cleaning.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 (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16427053
• MDR Text Key: 310372599
• Report Number: 9610595-2023-03052
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

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-150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 07/14/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2013
• 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