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

Catalog Number NTSE-022115-UDH

Device Problem Break (1069)

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

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: postal code: (b)(6).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

It was reported, during a right retrograde intrarenal surgery (rirs) with double j (dj) stenting using a ncircle tipless stone extractor, the basket broke.It is unknown how the procedure was completed.No piece of the device remained inside of the patient's body.The patient did not require any additional procedure due to this occurrence.Additional information has been requested.At this time, no other information is known.A follow up report will be submitted.If additional details requested are received.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Cook was informed on 03/02/2020 of an incident involving a ncircle tipless stone extractor.The device reportedly was found to have a broken basket during a retrograde intrarenal surgery procedure on (b)(6) 2020.Further communication with the user facility clarified that the issue was that the basket would not open.The patient reportedly experienced no additional harm as a result of the issue.Investigation - evaluation: a document-based investigation was performed including a review of complaint history, device history record, manufacturing instructions, quality control data, and the instructions for use (ifu).The complaint device was not returned; therefore, no physical examinations could be performed.There is no evidence to suggest the product was not made to specifications.No product was returned.No photos were provided.A search of the north american distribution center (nadc) database found all devices from the complaint lot have been shipped.Therefore, there were no similar product from the same lot is available for investigation.A review of the device history record (dhr) 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 are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot 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.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The complaint device was not returned for investigation.For the reported issue that the basket would not open during the case, there are multiple possible causes.It was stated that the device was tested prior to use.Without the device available for investigation, the cause for the failure of the basket to open could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database 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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, d11.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 received on 19mar2020: the device failure was that the basket would not open.It was tested prior to use.The stone that was attempting to be retrieved was 8mm.The outcome for the patient was good.The procedure was completed by the "physician has used laser to dust the stone.".

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation - evaluation: the device was returned after the previous mdr was submitted.This follow up report is to report the findings of our device evaluation.A visual inspection and functional testing of the returned device was conducted.One ncircle tipless stone extractor was returned for investigation.The device was returned with the handle in the open position and the basket formation in the closed position.The mlla [male luer lock adapter] was tight and the collet knob was tight and secure.A functional test determined the handle did not actuate the basket formation.The handle was disassembled during the investigation.The basket formation could not be manually actuated.The basket sheath could not be moved.Something appeared to be keeping the basket sheath from moving.The returned device was found to have a basket that was closed and could not be opened.The handle was disassembled and the basket could not be opened with the handle removed, the basket assembly was stuck inside the basket sheath.The information provided stated the device was tested before use, and that the issue occurred during use, therefore the basket was functional prior to the procedure.The cause for the failure of the basket to open could not be determined, but it is possible that an unknown procedure related event occurred that prevented the basket from opening, such as a small stone or other object became stuck inside the sheath.

Event Description

No new patient or event information since the last report was submitted.

• 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: 9828789
• MDR Text Key: 183354869
• Report Number: 1820334-2020-00604
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002187785
• UDI-Public: (01)10827002187785(17)200317(10)7756336
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/14/2020

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: 03/17/2020
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 7756336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/13/2020
• Supplement Dates Manufacturer Received: 03/19/2020; 04/03/2020; 06/26/2020
• Supplement Dates FDA Received: 03/20/2020; 04/15/2020; 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3.6FR FLEX X2 (KARL STORZ) SCOPE
• Patient Age: 35 YR
• Patient Weight: 65