MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. INFINITY ERCP SAMPLING DEVICE; ENDOSCOPIC CYTOLOGY BRUSH

Catalog Number 00711652

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2015

Event Type  No Answer Provided  

Event Description

During the procedure it was noticed that a foreign body was in the biliary duct.It was retrieved with no complications or injury to the patient.It was noticed that the object was from the biliary cytology brush that was used for the procedure.

• Brand Name: INFINITY ERCP SAMPLING DEVICE
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd.; mentor OH 44060
• MDR Report Key: 4663338
• MDR Text Key: 15381855
• Report Number: 4663338
• Device Sequence Number: 1
• Product Code: FDX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Physician
• Device Catalogue Number: 00711652
• Device Lot Number: 1410424
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2015
• Patient Sequence Number: 1
• Patient Age: 54 YR