MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SINGLE USE DISTAL COVER

Model Number	MAJ-2315
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a therapeutic esophagogastroduodenoscopy (egd), upper gastrointestinal (gi) ultrasound (us), and endoscopic retrograde cholangiopancreatography (ercp) procedure the distal cover fell off of the duodenovideoscope.It was reported that the cover fell into the esophagus and punctured the endotracheal (et) tube, but no soft tissue was punctured.The cover was retrieved with graspers.The retrieval time took less than 5 minutes while the patient was under general anesthesia.The event occurred when the physician was finishing the procedure, therefore no intervention was done for the punctured et tube and it was removed for the patient's emergence from anesthesia.There was no reported patient impact.This report is related to the following linked patient identifier: (b)(6).E1/establishment name: the board of trustees of the univ of ar acting for & on behalf added here due to character limitation in respective field.
Event or Problem Description
This report is being supplemented to correct d4 - unique identifier (udi) number.Updated from (b)(4) to (b)(4).

• Brand Name: SINGLE USE DISTAL COVER
• Common Device Name: DISTAL COVER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• MDR Report Key: 19291947
• Report Number: 2429304-2024-00252
• Device Sequence Number: 8693180
• Product Code: FDT
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024
• Report Date (Section F): 05/02/2024

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
• Operator of Device: Health Professional
• Device Model Number: MAJ-2315
• Device Lot Number: H2131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/20/2024
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 06/20/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TJF-Q190V (SERIAL # (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male