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

Catalog Number NCT4-024115

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: operating theater nurse manager.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, prior to the start of a ureteroscopy in the kidney, using a ncompass nitinol tipless stone extractor, the scrub nurse noticed the stone extractor shaft located above the handle was kinked.A new stone extractor was opened to continue the procedure.The issue with this device was discovered prior to making contact with the patient and it was not used.No adverse events have been reported as a result of the alleged malfunction.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.It was reported, prior to the start of a ureteroscopy in the kidney, using a ncompass nitinol tipless stone extractor, the scrub nurse noticed the stone extractor shaft located above the handle was kinked.A new stone extractor was opened to continue the procedure.The issue with this device was discovered prior to making contact with the patient and it was not used.Investigation ¿ evaluation.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, the instructions for use, manufacturing instructions, and quality control data.One device was returned for investigation.Inspection of the returned device noted it was returned with the handle in the open position and the basket formation in the closed formation.The mlla (male luer lock adapater) was loose, while the collet knob was tight and secure.The polyethylene terephthalate tubing (pett) measured 2.5 cm in length.The support sheath was severed 3 mm from the mlla.5 mm of the coil was exposed and noted to be offset.No other kinks or damage were found in the basket sheath.The basket sheath was severed.Functional testing noted the handle could not actuate the basket.A review of the device history record found no non-conformances related to the reported failure mode.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 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.A review of complaint history records shows no other complaints associated with the complaint device lot.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 closed and could not be opened due to sheath damage.The basket sheath and yellow support sheath were both separated near the device handle.The separated sheaths prevented the motion of the handle from opening the basket.The cause for the sheath damage could not be determined.The provided information stated the issue occurred before patient contact.It is possible the device was damaged during unpacking and/or subsequent handling.It is also possible that the device was damaged during shipping, or when loading the device into the device tray.There is not enough evidence to make a conclusion as to the cause of the damage.Per the quality engineering risk assessment, no further action is warranted.Cook 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 to report.

• 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: 10038277
• MDR Text Key: 199990131
• Report Number: 1820334-2020-00923
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002327013
• UDI-Public: (01)10827002327013(17)210319(10)8672970
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

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: 03/19/2021
• Device Catalogue Number: NCT4-024115
• Device Lot Number: 8672970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/08/2020
• Supplement Dates Manufacturer Received: 06/11/2020
• Supplement Dates FDA Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1