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 06/14/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device referenced in this report was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure, the rotatable grasping forceps got stuck in the elevator channel lever on the evis exera ii duodenovideoscope and the elevator lever would not go down.The issue was detected when using the rotatable grasping forceps to reposition the pancreatic stent.After adjusting angle of elevator, the forceps became caught.The gastroenterologist was controlling the scope and adjusted the angle of elevator then went to advance the forceps and found the forceps could not advance or be withdrawn.The intended procedure was completed successfully with a evis exera iii gastrointestinal videoscope to reposition the pancreatic stent with the rotatable grasping forceps.No additional treatment was required.No patient injury reported.

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.Based on the results of the investigation, a definitive root cause could not be established.Although the device was not returned to the manufacturer for an evaluation , the suggested phenomenon was presumed to have been due to the following: i) rat tooth forceps, which was used in combination with the subject device during the procedure had abnormality, or the user mishandled the rat tooth forceps.Ii) since the rat tooth forceps got stuck at forceps elevator of the subject device, movement of forceps raising was hindered.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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15040184
• MDR Text Key: 298039108
• Report Number: 9610595-2022-00050
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170339967
• UDI-Public: 04953170339967
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2016
• 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
• Treatment: OLYMPUS ROTATABLE GRASPING FORCEPS, FG-44NR-1