MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT OLYMPUS AND SINGLE USE DISTAL COVER; ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM

Model Number MAJ-2315

Patient Problems Airway Obstruction (1699); Foreign Body In Patient (2687)

Event Date 11/02/2023

Event Type  Injury  

Event Description

During an endoscopic procedure, the single use distal cover that is a flexible piece of plastic came off the end of the endoscope and went down into the patient's trachea partially obstructing her airway.Interventional pulmonology was called and did a flexible bronch to retrieve the cap.The same type of flexible, disposable cap that has just started to be used here at our institution, came off in another procedure and dropped into the hypopharynx of that patient.

• Brand Name: OLYMPUS AND SINGLE USE DISTAL COVER
• Type of Device: ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
• MDR Report Key: 18088278
• MDR Text Key: 327643734
• Report Number: MW5147874
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2023

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 Catalogue Number: H22X137
• Device Lot Number: H2X20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Race: Black Or African American