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	Unspecified Tissue Injury (4559)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that during a diagnostic procedure while using the evis exera iii duodenovideoscope, the single use distal cover came off and went into the patient's airway.This occurred within the first 5-10 minutes of the procedure.The patient required intubation and the cover was then removed.There was an extended procedural time frame as the procedure was about 45 minutes in duration.The procedure was completed with another scope.Due to the intubation, the patient did sustain some mucosal irritation.The patient was sent to the recovery room instead of short stay.There was no death or long term injury.Patient identifier (b)(6) is for the single use distal cover.Patient identifier (b)(6) is for the evis exera iii duodenovideoscope.
Event or Problem Description
This report is being supplemented to correct d4 - unique identifier (udi) number 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; tokyo, japan 190-0 182; JA 190-0182
• MDR Report Key: 16943467
• Report Number: 2429304-2023-00113
• Device Sequence Number: 8062054
• Product Code: FDT
• UDI-Device Identifier: 04953170441271
• UDI-Public: 04953170441271
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 12/06/2023
• Report Date (Section F): 04/20/2023

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
• Operator of Device: Health Professional
• Device Model Number: MAJ-2315
• Device Lot Number: H2614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/29/2023
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2023
• 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: 05/16/2023
• Supplement Report FDA Received Date: 12/06/2023
• 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: EVIS EXERA III DUODENOVIDEOSCOPE ¿ SERIAL (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown