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

Catalog Number	NC3-024115
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2017
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
Dr.(b)(6) and his assistant discovered before the operation that sheath near the handle was taken off from the ncompass nitinol stone extractor and it was squashed.The device was not used.The device did not make contact with the patient.There were no adverse consequences or effects to the patient as a result of this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was also conducted.A review of complaint history, the device history record, quality control data, and specifications was performed.One device was returned for investigation.The device was returned with the handle in the closed position.The basket formation is partially open.A functional test determined the handle does not actuate the basket formation.The collet knob is tight and secure.The male lure lock adaptor (mlla) is loose.The polyethylene terephthalate tubing (pett) measures 1.5 cm in length.A visual examination noted the support sheath is bent at the nose of the mlla and beyond that the support sheath is bowed.The basket sheath is partially separated 3 mm from the distal end of the support sheath and appears to have wires exposed in that location.The device appears used.It appears the device met resistance beyond its intended design.The complaint is confirmed.There is no indication that a design or process related failure mode contributed to this event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.A review of the device history record showed one non-conformance for an incorrectly applied label.A review of complaint history revealed this complaint to be the only reported complaint associated to the complaint lot number ns8004885.Based on the provided information a definitive root cause cannot be established.Per the quality engineering risk assessment, no further action is required.Measures have been initiated to address the reported failure mode.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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: 6896695
• Report Number: 1820334-2017-03242
• Device Sequence Number: 569350
• Product Code: FFL
• UDI-Device Identifier: 00827002327023
• UDI-Public: (01)00827002327023(17)200620(10)NS8004885
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2018

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: 09/18/2017
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1