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

Catalog Number	NTSE-030115-UDH-MB
Medical Device Problem Codes	Break (1069); Kinked (1339)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 that when the cook district manager received the ncircle tipless stone extractor the handle was not completely in its container.The handle was pushed back into the container and it was noticed that the wire of the basket was also damaged.A visual examination of the sealed package noted the basket formation appears kinked and pulled.An observation of the basket formation noted that one of the wires is severely kinked.Upon the first actuation of the handle, two of the wires broke.No patient involvement.
Additional Manufacturer Narrative
Evaluation / investigation: a visual inspection and functional testing of the returned device was conducted.A review of complaint history, the device history record, drawings, quality control data, and specifications was also performed.One unopened package was returned for investigation.A visual examination of the sealed package noted the basket formation appears kinked and pulled.The package was opened for investigation.The collet knob is tight and secure and the male luer lock adapter (mlla) is tight.There was no damage noted to the basket sheath.An observation of the basket formation noted that one of the wires is severely kinked.Upon the first actuation of the handle, two of the basket wires broke 5 mm from the knob.A review of the device history record found no non-conformances related to the reported failure mode.A review for additional complaints for this device lot found revealed this complaint to be the only complaint associated with lot number 8445982.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.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Based on the provided information a definitive root cause cannot be established.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.

• 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: 7312768
• Report Number: 1820334-2018-00594
• Device Sequence Number: 1656063
• Product Code: FFL
• UDI-Device Identifier: 00827002178724
• UDI-Public: (01)00827002178724(17)201214(10)8445982
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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: NTSE-030115-UDH-MB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1