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

Catalog Number NCT4-024115

Device Problem Break (1069)

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

Event Date 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

(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 that during an unknown point of a ureteroscopy, a ncompass nitinol tipless stone extractor broke where the handle and yellow sheath meet.It is unknown how the procedure was completed.No adverse effects to the patient have been reported.Additional patient and event information has been requested.At this time, no other information is known.A follow up report will be sent if additional details become available.

Manufacturer Narrative

Investigation ¿ evaluation.Cook was informed on 02/11/2020 of an incident involving a ncompass nitinol tipless stone extractor.The device reportedly was found to be broken at the handle during a ureteroscopy procedure.Attempts to acquire additional information from the user facility were executed, however no additional information was provided to cook in response to this incident.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, drawings, the instructions for use, manufacturing instructions, specifications, and quality control data.One ncompass nitinol tipless stone extractor was returned for investigation.Inspection of the device noted it was returned with the handle between the open and closed positions and the basket formation in the closed position.The mlla (male luer lock adapter) was loose.The collet knob was tight and secure.The polyethylene terephthalate tubing [pett] measured 3.5 cm in length.There was 3.5cm of the cannulated handled/coil assembly exposed.The remaining support sheath was secure.Functional testing determined the handle does not actuate the basket formation.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 returned device was found to have a basket that was not functional due to sheath damage.The device was damaged near the handle, with the yellow support sheath separated and the cannulated handle kinked and bent.The damage was preventing the basket from functioning.It was possible the device suffered handling damage during use, but there is not enough evidence to make a conclusive determination of the cause.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.

Event Description

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

• Brand Name: NCOMPASS NITINOL 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: 9749773
• MDR Text Key: 200259725
• Report Number: 1820334-2020-00446
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002327013
• UDI-Public: (01)10827002327013(17)221015(10)10083392
• 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
• Report Date: 03/26/2020

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: 10/15/2022
• Device Catalogue Number: NCT4-024115
• Device Lot Number: 10083392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 02/25/2020
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1