MAUDE Adverse Event Report: COOK MEDICAL CAPTURA HELICAL STONE EXTRACTOR

Model Number	CEF-432115
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The cook captura helical stone extractor malfunctioned during procedure.

• Brand Name: CAPTURA HELICAL STONE EXTRACTOR
• Common Device Name: CAPTURA HELICAL STONE EXTRACTOR
• Manufacturer (Section D): COOK MEDICAL; bloomington IN 47404
• MDR Report Key: 7159790
• Report Number: MW5074342
• Device Sequence Number: 1812898
• Product Code: FFL
• UDI-Device Identifier: 00827002327504
• UDI-Public: 00827002327504
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/29/2017

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
• Operator of Device: Health Professional
• Device Model Number: CEF-432115
• Device Lot Number: 8172198
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Weight: 88