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

Model Number TJF-Q170V

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Bronchial Hemorrhage (4456); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

The device was returned to olympus for evaluation.Upon testing of the returned device, the reported problems of blurred image and an insertion tube defect were not confirmed.The evaluation found the following: the foreign material on the device was described as yellow/ brown and identification remains uncertain.The adhesive on the bending section cover (a-rubber) was found detached.The investigation is ongoing, and the definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

A field service engineer reported to olympus on behalf of a customer that during an endoscopic retrograde cholangiopancreatography, blurred image was observed on a duodenovideoscope and an insertion tube defect.In addition, there was difficulty inserting the scope at the cricopharynx and antrum level.The procedure was delayed for two hours.Upon follow-up, inadequate cleaning of the distal end area was noted, and the distal cover was reportedly reused.Moreover, there was a delay when reprocessing was initiated.This report is being submitted for the procedural delay of 2 hours and foreign material left in the forceps elevator due to inadequate cleaning.

Event Description

Additional information was obtained from the customer: the device was inspected before use.At the start of the ercp procedure, the operating health care professional had difficulties inserting the tjf-q170v scope through the patient's pharynx into the esophagus, as well as from the esophagus into the gastric antrum.The customer stated the inability to insert the scope led to the procedure delay of 2 hours and this included change over time from subject device to another similar olympus device.While withdrawing the scope, bruises (with minor bleeding) near the throat / antrum were found.The information on whether additional anesthesia was given was not available.

Manufacturer Narrative

This report is being supplemented to provide additional information obtained from the customer and results of the 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, it was difficult to insert the device through the patient from pharynx into esophagus, as well as from esophagus into gastric antrum, causing a delay in the procedure, because of the blurry image.Additionally, the customer reported reusing the distal cover and a delay in starting reprocessing.Therefore, the forceps elevator had foreign material because reprocessing at the user facility deviated from the instructions for use.The instructions for use includes the detection method in gif/cf-170 series operation manual chapter 3 preparation and inspection.The instructions for use also includes the preventive measures in gif/cf-170 series reprocessing manual chapter 5 reprocessing the endoscope.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: 16542360
• MDR Text Key: 311290636
• Report Number: 9610595-2023-04333
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• 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: 02/12/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2022
• 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
• Patient Outcome(s): Other