MAUDE Adverse Event Report: COOK INCORPORATED FUSION; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number G31905

Device Problems Break (1069); Mechanical Jam (2983)

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

Event Date 04/06/2017

Event Type  Injury  

Event Description

Doctor inserted extraction basket into duct during ercp (endoscopic retrograde cholangio-pancreatography).While attempting to pull the basket out wire broke and basket became stuck in duct.

• Brand Name: FUSION
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6510618
• MDR Text Key: 73341228
• Report Number: 6510618
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2019
• Device Model Number: G31905
• Device Catalogue Number: FS-XB-2X4
• Device Lot Number: W3725546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 57 YR