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

Model Number TJF-Q180V

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 05/02/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for annual maintenance.In addition to evaluation in b5, due to wear of lock engagement lever, up/down knob could not be locked securely.The air/water cylinder had discoloration.The suction cylinder had discoloration.The up/down knob was shaved.The switch box had a scratch.Forceps channel port had a dent.Due to a chip on distal end, water tightness was lost.The image guide protector had a scratch.The light guide lens had a crack.The distal end was shaved.The adhesive around the objective lens had a crack.There was corrosion around the forceps elevator.The universal cord had coating peeling.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

A customer returned an evis exera ii duodenovideoscope to olympus for annual maintenance.There was no complaint or patient harm associated with this maintenance.During incoming inspection, the forceps elevator and connecting tube had foreign material due to insufficient cleaning.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 (h4/h6/h10).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 root cause could not be determined.It was confirmed that foreign material was found in the forceps elevator and insertion tube.The specific material could not be identified and the cause of the material remaining in the device could not be conclusively specified.It is likely reprocessing steps were not properly performed at the user facility due to the discovered leakage at the distal end.The event can be detected by following the instructions for use (ifu) which state: "-inspection of the endoscope" 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 (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: 16969826
• MDR Text Key: 315648994
• Report Number: 9610595-2023-07796
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170367311
• UDI-Public: 04953170367311
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• 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: 05/10/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2010
• 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