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

Catalog Number NTSE-015115

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) number: 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, the basket of an ncircle tipless stone extractor would not close when the device was tested prior to a ureteroscopy and stone removal procedure.Another device was used to complete the procedure.The device did not make patient contact.No adverse effects have been reported to the patient as a result of this occurrence.

Manufacturer Narrative

Event summary: as reported, the basket of an ncircle tipless stone extractor would not close when the device was tested prior to a ureteroscopy and stone removal procedure.Another device was used to complete the procedure.The device did not make patient contact.No adverse effects have been reported to the patient as a result of this occurrence.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.One ncircle tipless stone extractor was returned for investigation with the handle and basket formation in the open position.The handle was severed from the basket sheath/coil assembly at the support sheath.The basket sheath measured 113.9cm in length from the point of separation.The handle was disassembled, and the cannulated handle was found to be bent and severed at the junction at which it connects to the coil assembly.A document-based investigation evaluation was also performed.No related non-conformances were recorded, and no other lot-related complaints have been received.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.There were no identified gaps in the device manufacturing instructions or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions which caution, ¿do not use excessive force to manipulate this device.Damage to the device may occur.¿ the returned device was found to have the basket sheath/basket assembly severed from the handle.The provided information stated the basket would not close and did not mention the sheath separation.The sheath damaged prevented testing of the basket function.Based on the available information, cook has concluded that a cause for the device separation could not be determined.Cook will continue monitoring of similar complaints and have 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.

Event Description

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

• 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: 10874648
• MDR Text Key: 218674546
• Report Number: 1820334-2020-02166
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002462066
• UDI-Public: (01)10827002462066(17)221113(10)10148570
• 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: 01/18/2021

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: 11/13/2022
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 10148570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 12/30/2020
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1