MAUDE Adverse Event Report: COOK INC N-COMPASS NITINOL STONE EXTRACTOR; LQR DISLODGER, STONE BILIARY

Catalog Number C-NTSE-2.4-115-NC3

Device Problem Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: k173009.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 prior to use, the basket of a n-compass nitinol stone extractor was unable to be opened.The device did not make patient contact.Additional information regarding the patient and event has been requested but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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 Description

In additional information received on 08mar2021, it was reported that another like device was used to complete the intended procedure without any adverse effects to the patient.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation: beijing prime medical equipment co., ltd informed cook on (b)(6) 2021 of an incident involving a n-compass nitinol stone extractor (rpn: c-ntse-2.4-115-nc3) from lot # 13319782.The basket of the device reportedly could not be opened before use on 07jan2021.A review of documentation including the complaint history, device history record, instructions for use (ifu), manufacturing instructions, 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 was returned for evaluation.The returned device was found to have a basket that was closed and could not be opened due to sheath damage.The basket sheath was detached from the yellow support sheath and the support sheath was separated near the handle.It was also noted the distal end of the basket sheath was smashed.Cook has concluded that the device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient inspection activities are in place to identify this failure mode prior to distribution.The product specification for the n-compass nitinol stone extractor c-ntse-2.4-115-nc3 was reviewed and all extractors are 100% verified to assure the basket opens and closes properly.A review of the device history record (dhr) for lot 13319782 found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with this lot number.Because there were 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, examination of the returned product and the results of our investigation, a definitive root cause for the failure could not be determined.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We 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.

• Brand Name: N-COMPASS NITINOL STONE EXTRACTOR
• Type of Device: LQR DISLODGER, STONE BILIARY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11273042
• MDR Text Key: 266302343
• Report Number: 1820334-2021-00241
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 10827002362502
• UDI-Public: (01)10827002362502(17)230217(10)13319782
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2023
• Device Catalogue Number: C-NTSE-2.4-115-NC3
• Device Lot Number: 13319782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1