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

Catalog Number NTSED-024115-UDH

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: buyer.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported in an unspecified procedure using a ncircle delta wire tipless stone extractor, the wire disconnected from the hand piece.It is not known how the procedure was completed after this difficulty was experienced.No adverse effects to the patient have been reported as a result of this occurrence, and there is no report of any fragment of the device remaining inside the patient.Additional details regarding this patient and event have been requested.At this time, no additional information has been provided.18jun2020mah.

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

Additional information provided (b)(6) 2020: the patient was covid-19 negative.The patient did not have prolonged hospitalization due to this occurrence.No other patient or event information is available.

Event Description

Additional information was received 30jun2020: the procedure being performed was a ureteroscopy.The alleged malfunction was discovered prior to the device making contact with the patient and it was not used.A second stone extractor was used to complete the procedure.

Manufacturer Narrative

It was reported, the device suffered damage near the handle before use.A second stone extractor was used to complete the procedure.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record (dhr), drawing, manufacturing instructions, the instructions for use, and quality control data.One ncircle delta wire tipless stone extractor was returned for investigation.Inspection of the returned device noted: the device was returned with the handle between the open and closed positions with the basket formation in the closed position.The mlla [male luer lock adapter] was tight.The collet knob was tight and secure.Functional testing determined the handle did not actuate basket formation.With the handle in the open position, the support sheath was severed 1 mm past the nose of the mlla.The cannulated handle was kinked at the junction of the handle and the coil assembly.1 cm of cannulated handle and 1 cm of coil assembly were exposed.The remaining support sheath and basket sheath were still attached.The coil was offset.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.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 that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precaution: enclose the device in the sheath before removing from the tray/holder.Precaution: do not use excessive force to manipulate this device.Damage to the device may occur.The returned device was found to have a basket that was closed and could not be opened due to damage near the handle.The yellow support sheath was separated and the basket assembly was severely kinked where the basket coil connects to the cannulated handle.All devices are inspected for proper functioning and damage during manufacturing and quality control checks.The devices are also packaged with the basket in the open position, the observed damage would have prevented the device from being placed inside the shipping tray, indicating the device was not received by the customer with the damage.The available evidence indicates the device was inadvertently damaged when removing it from the packaging, or during subsequent handling.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.We will continue to monitor for similar complaints 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.

• Brand Name: NCIRCLE DELTA WIRE 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: 10179370
• MDR Text Key: 196424878
• Report Number: 1820334-2020-01160
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002191102
• UDI-Public: (01)10827002191102(17)230325(10)13082202
• 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: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2023
• Device Catalogue Number: NTSED-024115-UDH
• Device Lot Number: 13082202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1