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 Foreign Body In Patient (2687)

Event Date 04/14/2023

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a medwatch report (mw5116634) which reported that the single use distal cover came off from the evis exera iii duodenovideoscope during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The scope entered the intestines via laparoscopy trocar.The procedure was done via laparoscopic trocar because the patient's prior bariatric surgery caused her to have an altered anatomy.It was believed that the cap came off as the scope was being withdrawn through the trocar.The trocar measured 15 millimeters (mm) and the scope was 13.5 mm.After the scope was fully withdrawn, the staff observed that the cap was missing from the scope and began the search in the bowel loops, surgical drapes, and the floor.An x-ray prior to case closure was not possible as the cap was not radiopaque.A computerized tomography (ct) scan of the abdomen and pelvis performed the next day did not show a cap.It was believed that the cap was left in the gastrointestinal tract and will pass spontaneously.There was no further harm or user injury reported due to the event.This event is reported under the following patient identifiers: (b)(6)- single use distal cover.(b)(6)- evis exera iii duodenovideoscope.

• 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: 17014429
• MDR Text Key: 316097192
• Report Number: 2429304-2023-00120
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/28/2023,05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MAJ-2315 / H2613.
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White