MAUDE Adverse Event Report: COOK INC NCIRCLE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event requested but not provided.(b)(4).The event is currently under investigation.
Event or Problem Description
According to the initial reporter, the basket retrieval broke off in the patient.During the procedure.Additional information has been requested, however it was not provided at the time of this report.
Additional Manufacturer Narrative
(b)(4).Investigation/evaluation during the course of the investigation a visual inspection, along with a review of the complaint history of the product was conducted.The complaint product was returned in three separate sections and it appears that the wire snapped at the distal end of the basket.Tensile testing is completed 100% to ensure the device can withstand tensile force.In addition, inspectors confirm the functionality of the product.This break may have potentially been related to the size and/or shape of the stone as the breakage occurred during retrieval.The stone may have been stuck in a tortuous anatomy and while retrieving it, excessive tensile forces may have been applied to the basket during retrieval.Thus causing the breakage.However, based on the information provided, a definitive root cause cannot be determined.We will continue to monitor for similar complaints.Per the risk assessment (ra) no further action is required.
Event or Problem Description
According to the initial reporter, the basket retrieval broke off in the patient.During the procedure.Additional information has been requested, however it was not provided at the time of this report.

• Brand Name: NCIRCLE TIPLESS STONE EXTRACTOR
• Common Device Name: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5464126
• Report Number: 1820334-2016-00132
• Device Sequence Number: 397226
• Product Code: FFL
• UDI-Device Identifier: 00827002187771
• UDI-Public: (01)00827002187771(17)170501(10)4999635
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NTSE-022115-UDH-MB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2016
• Supplement Report FDA Received Date: 07/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1