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 Date 09/21/2021

Event Type  malfunction  

Event Description

The customer reported that it was not possible to pass instruments down the biopsy channel of the subject device.The reported issue was observed during an unspecified procedure.There was no report of patient or user injury due to the event.

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.The subject device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, the customer's complaint was confirmed.It was observed that the forceps could not be inserted or removed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over 8 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, although a conclusive root cause could not be determined, it is likely the forceps could not be inserted or removed due to following: the event occurred due to deformation of the forceps channel, the event occurred due to breakage of the instrument, or the event occurred due to foreign material in the forceps channel.The following information is stated in the ifu (instructions for use) which may help to prevent the issue: operation manual.3.8 inspection of the endoscopic system, inspection of the instrument channel and forceps elevator; operation manual.Important information: please read before use.Precautions.Operation manual.3.6 inspection of ancillary equipment.Operation manual.4.3 using endotherapy accessories.Reprocessing manual.5 reprocessing the endoscope (and related reprocessing accessories).Reprocessing manual.7 reprocessing endoscopes and accessories using an aer/wd.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: 15905846
• MDR Text Key: 308187517
• Report Number: 9610595-2022-04795
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170339967
• UDI-Public: 04953170339967
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• 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: 09/21/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0379-2022
• Patient Sequence Number: 1