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

Model Number	G19072
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510k #: exempt.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 is reported while preparing for a uretero-lithotripsy procedure using a nforce nitinol helical stone extractor, "it was identified that the tip of the catheter was kneaded." there was no break/separation in the basket.There was no scope or laser used with this device.This device did not come into contact with the patient.The procedure was completed by opening another extractor.No adverse effects to the patient have been reported as a result of this alleged product malfunction.Additional details were requested regarding the patient and event.It was reported no additional information is available.
Event or Problem Description
There is no new event information to report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was completed including a review of complaint history, the device history record, drawings, instructions for use, manufacturing instructions, and quality control data.One device was returned for investigation.The returned packaging confirms the reported lot number.The device was returned with the handle in the closed position and the basket formation partially opened.Functional testing determined the handle actuates the basket formation to the open position, but it does not retrieve the basket formation completely into the basket sheath.It bends over at the tip.With the handle in the closed position, the closed basket formation extends 1 cm from the distal tip of the basket sheath.Visual examination noted one of the basket wires appears straighter than the others.The straighter wire appears shorter than the other wires.The straighter wire measures 2.4 cm from the distal cannula to the distal sheath.The twisted wires measures approximately 2.5 cm from the distal cannula to the distal sheath.A review of the device history record found there were no non-conformances.A lot history search found no other complaints have been reported on this lot.The instructions for use (ifu), provides the following information related to the reported failure mode: precaution: enclose the device in the sheath before removing from the tray/holder.Precaution: do not use excessive force to manipulate this device.Damage to the device may occur.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 and device integrity prior to shipping.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.The basket of the returned device was found to be misshaped.The basket did not form a proper shape when open, and folded back upon itself when closed.It was reported the issue occurred before use.All devices are inspected multiple times for damage and functionality prior to packaging, making it likely the basket became deformed during handling before use.No visible damage to the basket components such as kinking or bending was found.The cause for the deformation could not be determined.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: NFORCE NITINOL HELICAL 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: 8590631
• Report Number: 1820334-2019-01038
• Device Sequence Number: 16729181
• Product Code: FFL
• UDI-Device Identifier: 00827002190726
• UDI-Public: (01)00827002190726(17)211022(10)9251797
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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 Expiration Date: 10/22/2021
• Device Model Number: G19072
• Device Catalogue Number: NFHSES-022115-3W-UDH
• Device Lot Number: 9251797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1