MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE

Model Number TJF-Q180V

Device Problems Partial Blockage (1065); Device Reprocessing Problem (1091)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2021

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has been evaluated by olympus.Preliminary findings are reported.The investigation is ongoing.Upon evaluation/inspection of the device, olympus noted the nozzle was clogged with foreign matter, and the forceps channel had foreign matter present.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The customer reports while preparing an evis exera ii duodenovideoscope for use, the angulation knob felt too loose and there were wrinkles noted on insertion tube unit.Upon evaluation/inspection of the device, olympus noted the nozzle was clogged with foreign matter, and the forceps channel had foreign matter present indicating insufficient reprocessing.

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.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "3.5 manual cleaning: brushing around the forceps elevator and instrument channel outlet the following description is included in ifu (reprocessing manual).3.3 precleaning: if the endoscope is not immediately cleaned after each procedure, residual organic debris will begin to solidify and it may be difficult to effectively reprocess the endoscope." three attempts were performed to obtain occupation for the reporter but were not successful.If additional information is obtained at a later date, a supplemental report will be submitted.Olympus will continue to monitor the field performance of this device.

Manufacturer Narrative

This report is being supplemented to provide additional information received.The date of the event was added.The contact person's information was added to initial reporter name and address, initial reporter health professional and initial reporter occupation.

Manufacturer Narrative

Correction to date rec¿d by mfr of the initial medwatch.The aware date should be 19-dec-2021.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13283081
• MDR Text Key: 295324150
• Report Number: 8010047-2022-01573
• 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,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• 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: 12/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2018
• 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