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 Patient Involvement (2645)
Date of Event	11/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: unknown.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 a n-compass nitinol stone extractor was unable to be opened completely.This observation was made prior to patient contact.No adverse effects have been reported.
Additional Manufacturer Narrative
Investigation - evaluation.A review of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control, as well as a visual inspection and functional test of the returned device, was conducted during the investigation.One n-compass nitinol stone extractor without the collet was returned for examination.Upon visual inspection, the handle was in the open position while the basket formation was in the closed position.The cannulated handle was bent inside of the handle.Kinks in the coil and basket sheath were noted.The support sheath was also bowed and the collet knob was loose.Functional test determined that the handle does not actuate basket formation.When the handle is actuated, a kink in the coil is noticed protruding from the side.The basket formation was unable to be manually actuated.There is no evidence to suggest the product was not manufactured to specifications.Additionally, a document-based investigation evaluation was performed.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the complaint lot (9946836) and the related basket subassembly lot (ns9808421) revealed no related non-conformances.A database search found no other events associated with the provided complaint lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.Based on the information provided, inspection of the returned product, and the results of our investigation, a definitive root cause was not established.The observed damage was preventing the basket from opening.It is possible the device was damaged during unpacking and/or subsequent handling.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 9475503
• Report Number: 1820334-2019-03123
• Device Sequence Number: 19545936
• Product Code: GAE
• UDI-Device Identifier: 00827002362505
• UDI-Public: (01)00827002362505(17)220702(10)9946836
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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: 07/02/2022
• Device Model Number: N/A
• Device Catalogue Number: C-NTSE-2.4-115-NC3
• Device Lot Number: 9946836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1