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

Model Number MAJ-2315

Patient Problem Foreign Body In Patient (2687)

Event Date 08/10/2023

Event Type  Injury  

Event Description

Disposable ercp scope tip was found in patient's oral cavity upon suctioning in recovery.Item # maj-2315.

• Brand Name: OLYMPUS SINGLE USE DISTAL COVER
• Type of Device: ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.
• MDR Report Key: 17566038
• MDR Text Key: 321524027
• Report Number: MW5144684
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/14/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: MAJ-2315
• Device Catalogue Number: N57861F00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Sex: Male