MAUDE Adverse Event Report: COOK INC N-COMPASS NITINOL STONE EXTRACTOR; GAE SNARE, SURGICAL

Model Number	N/A
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma/510(k) #: 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 was reported that the basket of the n-compass nitinol stone extractor would not open fully during an endoscopic retrograde cholangio-pancreatography (ercp) procedure.The basket was found to be working properly when tested outside of the patient.However, when inside the patient during the procedure, the basket would not fully open.After a few unsuccessful attempts, a new basket was used to complete the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
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 and the basket formation in the closed position.Visual examination noted the support sheath is bowed starting at the male luer lock adapter (mlla).There are several kinks in the basket sheath starting 5 mm from distal tip, and again at 41 cm, 66 cm, 72 cm, and 81 cm from the distal tip of the basket sheath.The basket formation appears smashed in appearance and slightly off center.The basket weave is twisted and the basket wires appear pulled and stretched.Functional testing determined the handle actuates the basket formation to the opened and fully closed positions.A review of the device history records associated with the complaint device lot found there were no non-conformances related to this incident.A complaint history search also found no other complaints have been associated with this lot.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Instructions for use are not provided with this device.Although the basket of the device opened and closed fully during testing, the observed damage could have prevented the basket from functioning during use, when the device would have been in a tortuous path inside the scope.The cause for the damage could not be determined.The device was returned loose in the original pouch without the product tray, therefore it could not be determined what damage occurred during use and what occurred during return shipping.The cause for the complaint could not be conclusively 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.
Event or Problem Description
There is no new event information to report.

• Brand Name: N-COMPASS NITINOL STONE EXTRACTOR
• Common Device Name: GAE SNARE, SURGICAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8546145
• Report Number: 1820334-2019-00898
• Device Sequence Number: 16221692
• Product Code: GAE
• UDI-Device Identifier: 00827002362512
• UDI-Public: (01)00827002362512(17)211104(10)9346195
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2019

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: 11/04/2021
• Device Model Number: N/A
• Device Catalogue Number: C-NTSE-2.4-115-NCT4
• Device Lot Number: 9346195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1