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

Model Number TJF-Q190V

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/11/2023

Event Type  Injury  

Event Description

The customer reported to olympus that the single use distal cover came off from the evis exera iii duodenovideoscope.The issue was found at the end of a therapeutic, endoscopic retrograde cholangiopancreatography (ercp) which was completed using the same equipment.The cover was retrieved by the doctor at the time of the event.The procedure was extended for an unspecified amount of time during the search of the cap.There were no reports of patient harm.This event is reported under the following patient identifiers: (b)(6) - evis exera iii duodenovideoscope.(b)(6) - single use distal cover.

• 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
• MDR Report Key: 16910971
• MDR Text Key: 314995639
• Report Number: 2429304-2023-00091
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2023,05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Distributor Facility Aware Date: 04/11/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MAJ-2315/H228093
• Patient Outcome(s): Required Intervention
• Patient Sex: Unknown