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

Model Number TJF-150

Device Problems Peeled/Delaminated (1454); 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 was confirmed.Due to wear of angle wire, bending angle in right direction did not meet the standard value.In addition to evaluation in b5, the objective lens had a scratch.Plastic distal end cover had a dent.The adhesive on bending section cover was detached.Connecting tube had a scratch.Connecting tube had buckling.Due to wear of angle wire, the play of up/down knob was out of the standard value.Due to wear of angle wire, the play of right/left knob was out of the standard value.Grip was dirty.The up/down knob was dirty.The right/left knob was dirty.The control unit had a scratch.The scope cover had a scratch.The universal cord had a scratch.Light guide bundle was slipping down.The control unit had corrosion due to water leakage.Scope connector was dirty due to water leakage.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

An olympus field service engineer reported on behalf of a customer, there was an angulation problem in all directions with the duodenovideoscope.The event occurred during receipt inspection.There was no report of patient harm.During incoming inspection, the inside of light guide lens had foreign objects and forceps elevator had foreign material.The residual foreign material was due to insufficient cleaning.The subject device was not reprocessed before being returned to olympus.This medwatch is being submitted to capture the reportable malfunctions found during evaluation.

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, the foreign material could not be removed by reprocessing, because its adhering area was not external surface of the device.However, the cause of the event is likely due to the light guide (lg) lens glue was peeled by physical stress such as hitting or dropping the distal end, chemical stress due to chemical solutions used, or the like.Then humidity may have been allowed to go inside the lg-lens and caused corrosion.Therefore, the root cause of the reported event is unable to be determined.The event can be detected by following the instructions for use (ifu) which state: operation manual chapter 3 preparation and inspection.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: 16728752
• MDR Text Key: 313400672
• Report Number: 9610595-2023-06045
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• 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: 03/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2008
• 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