MAUDE Adverse Event Report: COOK INC NCIRCLE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Catalog Number NTSE-015115

Device Problem Material Separation (1562)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

It is unknown if the complaint device will be returned.This information has ben requested.Occupation: other non-healthcare professional: billing specialist.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 Description

As reported, a ncircle tipless stone extractor was being used, and the basket broke off and went into the patient's kidney.They physician was able to retrieve it from the kidney.Additional patient and event information has been requested.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Corrected information: b1,b2, b3, b5, d9, e4, h1, h3, h6.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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

Additional information was provided on (b)(6) 2021 that was not reported on the initial report: patient demographics are not available.The procedure was a ureteroscopy.The procedure was completed by using another basket.They believe the separated basket was retrieved using another basket or a grasper.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to this occurrence.No adverse effects were reported due to the occurrence.

Event Description

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

Manufacturer Narrative

Event summary: as reported, during a ureteroscopy, a ncircle tipless stone extractor was being used, and the basket broke off and went into the patient's kidney.They physician was able to retrieve it from the kidney using another basket or a grasper.The procedure was completed by using another basket.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection and functional test of the device were conducted during the investigation.Metal fragments of one ncircle tipless stone extractor was returned for investigation in gauze.Fragments of the coil assembly were returned stretched and pulled.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.The product specification for the ncircle delta wire tipless stone extractor ntsed-024115-udh was reviewed.All extractors are tested for basket assembly tensile strength.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which caution, ¿enclose the device in the sheath before removing from the tray/holder,¿ and, ¿do not use excessive force to manipulate this device.Damage to the device may occur.¿ it is possible that the device was unable to be easily removed during use, then a large force was then applied, causing the reported issue and observed damage.No information was provided that could identify the cause of the issue that prevented the device from being easily removed.Thus, cook has concluded that a cause for this event could not be determined.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.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.

• Brand Name: NCIRCLE TIPLESS STONE EXTRACTOR
• Type of Device: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11677317
• MDR Text Key: 264791240
• Report Number: 1820334-2021-01142
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002462066
• UDI-Public: (01)10827002462066(17)231112(10)13553533
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2023
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 13553533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 04/15/2021; 06/17/2021
• Supplement Dates FDA Received: 04/23/2021; 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention