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

Catalog Number	NC3-024115
Medical Device Problem Codes	Kinked (1339); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported the ncompass nitinol stone extractor wire kinked approximately 3cm from the basket handle, preventing operation of the basket.No unintended portion of the device remained inside the patient¿s body.No additional procedures were required due to this occurrence.No adverse effects or consequences were reported to the patient due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable or unchanged.Investigation ¿ evaluation.(b)(4).A review of manufacturing instructions, specifications, quality control data, documentation, visual inspection, and functional testing was conducted during the investigation.A document-based investigation evaluation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The complaint device was returned for evaluation.The device was found to be non-functional due to a severe sheath kink at the support tube.The ifu contains a caution to not use excessive force to manipulate the device, or damage to the device may occur.It is unknown if excessive force was used on the device.Based on the provided information a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: NCOMPASS NITINOL 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: 7171670
• Report Number: 1820334-2018-00035
• Device Sequence Number: 917429
• Product Code: FFL
• UDI-Device Identifier: 00827002327023
• UDI-Public: (01)00827002327023(17)200907(10)8198790
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2018

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 Catalogue Number: NC3-024115
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 01/08/2018
• Supplement Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1