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

Model Number TJF-Q180V

Device Problem Mechanical Jam (2983)

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

Event Type  malfunction  

Event Description

The subject device was received at an olympus service center for evaluation with a report that a clip was stuck in the working channel (instrument channel).There was no patient or user injury reported.During inspection and testing, service found that due to clogging of the instrument channel, the forceps could not be inserted or removed.This report is being submitted for the malfunction found during the device evaluation.

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.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, a definitive root cause could not be determined.However, the following are the potential causes: the event occurred due to deformation of the forceps channel.The event occurred due to breakage of the instrument.The event occurred due to foreign material in the forceps channel.Operation manual: inspection of the endoscopic system; inspection of the instrument channel and forceps elevator.Operation manual: important information ¿ please read before use; precautions.Operation manual: inspection of ancillary equipment; operation manual.Using endotherapy accessories: reprocessing manual; reprocessing the endoscope (and related reprocessing accessories).Reprocessing manual: reprocessing endoscopes and accessories using an aer/wd.During the device evaluation, service also found that due to clogging of the instrument channel, the tube cleaning brush could not be inserted.The scope connector was dented, and the scope cover unit was scratched.The objective lens was scratched, and adhesive around the objective lens and light guide lens was worn.The distal end was shaved.There was corrosion around the lever arm.The universal cord was scratched.Per the legal manufacturer, these other device issues identified by service have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16700527
• MDR Text Key: 313075438
• Report Number: 9610595-2023-05766
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170367311
• UDI-Public: 04953170367311
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• 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: 01/20/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2017
• 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