MAUDE Adverse Event Report: US ENDOSCOPY GROUP, INC. US ENDOSCOPY INFINITY ERCP SAMPLING BRUSH; CYTOLOGY BRUSH

Model Number 00711653

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/12/2019

Event Type  Injury  

Event Description

Radiopaque marker dislodged in common bile duct.Additional procedure needed to remove and treat.

• Brand Name: US ENDOSCOPY INFINITY ERCP SAMPLING BRUSH
• Type of Device: CYTOLOGY BRUSH
• Manufacturer (Section D): US ENDOSCOPY GROUP, INC.; mentor OR 44060
• MDR Report Key: 8470353
• MDR Text Key: 140540654
• Report Number: MW5085400
• Device Sequence Number: 1
• Product Code: FDX
• 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: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2021
• Device Model Number: 00711653
• Device Catalogue Number: 00711653
• Device Lot Number: 1809100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 84 YR
• Patient Weight: 99