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

Model Number MAJ-2315

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/20/2023

Event Type  Injury  

Event 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 Description

This report is being supplemented to correct d4 - unique identifier (udi) number to (b)(4).

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: 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
• MDR Text Key: 315354418
• Report Number: 2429304-2023-00113
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/20/2023,12/06/2023

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: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EVIS EXERA III DUODENOVIDEOSCOPE ¿ SERIAL (B)(6).
• Patient Outcome(s): Required Intervention
• Patient Sex: Unknown