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

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2020

Event Type  malfunction  

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 Description

It was reported that the basket of a n-compass nitinol stone extractor would not open "normally", and "the device didn't function as intended".The issue was noticed prior to patient contact and another device was used to complete the procedure.No adverse effects were reported.

Manufacturer Narrative

Investigation ¿ evaluation: distributor guangzhou hengkang trade co., ltd.Informed cook on 28jun2020 of an incident involving a n-compass nitinol stone extractor c-ntse-2.4-115-nct4 from lot # 9886627.The basket of the device reportedly did not open before use on 10jun2020.Another device was used to complete the procedure.A review of the complaint history, device history record, manufacturing instructions (mi), quality control, and inspection of unused product, as well as a visual inspection and functional test of the returned device, were conducted during the investigation.The unused complaint device was returned for evaluation.The device was returned with the handle and basket formation in the closed position.The male luer lock adapter was loose and the collet knob was tight and secure.A functional test determined the handle actuates basket formation to the open and closed positions.A visual examination noted no kinks in the basket sheath or issues with the device.The device was determined to be manufactured to specifications.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the device history record found no related nonconformances or additional complaints associated with this device lot.There is no evidence to suggest there is any nonconforming product in house or out in the field.Based on the information provided, inspection of the returned product, and the results of the investigation, a definitive cause for failure was not established.Although the device functioned normally when tested by cook, it is possible that the conditions under which the device was used by the customer prevented normal operation.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.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 Description

No additional patient/event information has been received since the previous medwatch report was sent.

• Brand Name: N-COMPASS NITINOL STONE EXTRACTOR
• Type of Device: GAE SNARE, SURGICAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10236099
• MDR Text Key: 198330648
• Report Number: 1820334-2020-01258
• Device Sequence Number: 1
• Product Code: GAE
• UDI-Device Identifier: 10827002362519
• UDI-Public: (01)10827002362519(17)220528(10)9886627
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• Device Model Number: N/A
• Device Catalogue Number: C-NTSE-2.4-115-NCT4
• Device Lot Number: 9886627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Manufacturer Received: 06/28/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1