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

Model Number TJF-Q170V

Device Problem Mechanical Jam (2983)

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

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation of elevator control not working was confirmed due to forceps raiser being stuck and forceps elevator did not move down at all.The device evaluation also found the following non-reportable findings: adhesive of bending section cover had peeled off, mouth guard piece for endoscopy had scratch, universal cord had scratch, and video cable tube unit had scratch.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the duodenovideoscope elevator control was not operating.The issue was found during preparation for use for a therapeutic endoscopic procedure.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additionally, further information was provided by the customer.It was confirmed there was no delay in the procedure which was completed using another device (tjf-q170, serial: (b)(6) ).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, it was confirmed that the forceps elevator was stuck to the distal end and the forceps elevator could not be controlled while being raised.No device leaks were detected.As the issue was detected during inspection prior to use, not during a procedure or reprocessing, it is possible that rust or the like was generated after reprocessing causing the defect.However, specific root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18360588
• MDR Text Key: 331077747
• Report Number: 9610595-2023-19919
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: VM
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q170V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2023
• 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