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 06/08/2021

Event Type  malfunction  

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.It has been over 7 years since the subject device was manufactured.During inspection and testing, service confirmed the customer¿s reported issue, and found there was no passage of the forceps or brush.Based on the results of the investigation, the possible causes for the event could have been due to deformation of the forceps/biopsy channel, breakage of the instrument, or foreign material in the forceps/biopsy channel.However, a definitive root cause could not be determined.The event may be detected by following the instructions for use which state: 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 service was unable to perform a leak test due to the clogged biopsy/forceps channel.The suction flow was clogged.The forceps elevator could not be checked due to the clogged channel.The guide wire tension was not smooth and was unable to check due to the clogged biopsy channel.The catheter movement was too light and unable to check the test due to the clogged biopsy channel.Dents and scratches were observed on the distal end plastic cover and control body.White debris was inside the light guide lens.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.

Event Description

The customer reported in the olympus service portal that during an unspecified procedure using the subject device, the user was unable to place a snare or a brush down the scope.There was no patient or user injury reported due to the event.No further information was provided.

• 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: 15871270
• MDR Text Key: 307923815
• Report Number: 9610595-2022-04558
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170367311
• UDI-Public: 04953170367311
• 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: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• 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: 06/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2015
• 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