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

Catalog Number	NCT4-024115-MB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: exempt.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported the ncompass nitinol tipless stone extractor basket probe broke during use in a laparoscopic cholecystectomy procedure.But did not separate from the device when the facility was trying to use it on a stone.A new stone extractor was opened and used to complete the procedure.The ifu clearly states the ncompass nitinol tipless stone extractor is intended for stone manipulation and removal in the urinary tract.No unintended section of the device fell inside the patient¿s body.No additional procedures were required.There were no adverse consequences or effects to the patient due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the product was not returned for evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.A documentation review of complaint history, the device history record, instructions for use, and quality control data was conducted.A review of the device history record found there were no non-conformance issues associated with the complaint device lot number.A search of complaint history records revealed no other complaints have been associated with the complaint device lot number 6503443.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.The instructions for use (ifu) contains the following: precautions: enclose the device in the sheath before removing from the tray/holder.Do not use excessive force to manipulate this device.Damage to the device may occur.Intended use: the ncircle, ncompass, and nforce stone extractors are intended for stone manipulation and removal in the urinary tract.Devices are inspected for damage and functionality prior to packaging.The device was being used for an "off label" application contrary to that specified in the instructions for use.The ifu states that the device is intended for stone manipulation and removal in the urinary tract.The device was used for a laparoscopic cholecystectomy procedure.It could not be determined if the off-label use caused or contributed to the reported issue.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: NCOMPASS NITINOL 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: 7361029
• Report Number: 1820334-2018-00599
• Device Sequence Number: 18875183
• Product Code: FFL
• UDI-Device Identifier: 00827002328631
• UDI-Public: (01)00827002328631(17)190107(10)6503443
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

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: NCT4-024115-MB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1