MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS SINGLE USE DISTAL COVER; ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM

Model Number MAJ-2315

Device Problem Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); Cough (4457)

Event Date 10/25/2022

Event Type  Injury  

Event Description

Patient was in the pacu after an ercp procedure that was performed in the endoscopy suite.She was chewing on ice chips when she began coughing and expelled the clear plastic cap, cat #maj-2315, which is used to cover the distal tip of the ercp scope.Fda safety report id# (b)(4).

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS
• MDR Report Key: 15720392
• MDR Text Key: 303059592
• Report Number: MW5113053
• 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: Unknown
• Type of Report: Initial
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: MAJ-2315
• Device Catalogue Number: MAJ-2315
• Device Lot Number: H1423
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other