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

Model Number TJF-Q190V

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/02/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.A supplemental report will be submitted if any additional information is provided by the user facility.

Event Description

The head nurse reported to olympus that mucosal injury occurred when the singe use distal cover was used in an unspecified procedure and a small piece of mucosal tissue was left behind the albaran lever of the evis exera iii duodenovideoscope.There were no reports of patient harm.Two complaints below have been created for reporting this event: related patient identifiers: complaint # (b)(6) , single use distal cover; maj-2315, serial number- unknown complaint # (b)(6) , evis exera iii duodenovideoscope, tjf-q190v, serial number- unknown (this complaint).

Event Description

The customer confirmed the procedure was a therapeutic ercp.The intended procedure was completed with the same device.The device was tested prior to use, and everything was ok.The current condition of the patient is fine.According to the customer the cap was the new design.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide a correction to the initial b1.Additionally, to provide additional information received through follow-up.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely the phenomenon occurred by the following: - the user operated suction with opening space of the scope distal end being close to mucosal surface, and mucosa was sucked in the distal cover.The subject scope was moved under that condition, and as a result mucosa was injured by edge of the distal cover.- the subject scope was moved immediately after suctioning (while mucosa was sucked in the distal cover).As a result, mucosa was injured.However, the root cause of the phenomenon could not be identified.The event can be prevented by following the instructions for use which state: "important information ¿ please read before use: examples of inappropriate handling" olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 17093244
• MDR Text Key: 317698059
• Report Number: 9610595-2023-08632
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K220587
• 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: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SINGLE USE DISTAL COVER, MAJ-2315, SN- UNKNOWN.