MAUDE Adverse Event Report: US ENDOSCOPY INFINITY; ENDOSCOPIC CYTOLOGY BRUSH

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/16/2022

Event Type  malfunction  

Event Description

Patient was in procedure for an endoscopic retrograde cholangiopancreatography (ercp).While doing the second brushing with the steris infinity ercp sampling device the end of the brush broke off in the patients bile duct leaving a foreign body in the patients bile duct.Full device retrieval completed with rat tooth forceps, biliary balloon sweeps and biopsy forceps.

• Brand Name: INFINITY
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): US ENDOSCOPY; 5960 heilsey road; mentor OH 44060
• MDR Report Key: 16426802
• MDR Text Key: 310062468
• Report Number: 16426802
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17885 DA
• Patient Sex: Female