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

Model Number	G32701
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510k #: exempt.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, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.The complaint device was returned for investigation.The returned packaging confirms the reported complaint device lot number.The device was returned with the handle in open position with the basket formation in the closed position.A visual examination notes: the support sheath is separated 1 mm from the male luer lock adapter (mlla), there was approximately 3.5 cm of exposed wires between where it was separated, a wire was bent in the cannulated handle at end of mlla, there was a kink in the basket sheath 3.5 cm from distal tip and 29 cm from distal tip of basket sheath, the support sheath and basket sheath are still adhered, and that the basket formation is still attached to the coil/basket assembly, it had been retracted in the basket sheath.A functional test determined the handle does not actuate the basket formation.A review of the device history record found no non-conformances.A review of complaint history records shows no other complaints associated with the complaint device lot.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 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 sheath damage.The basket was attached to the device, and was not missing as it was reported.The support sheath was separated at the handle.The cannulated handle was bent at the handle.The damaged sheath and bent cannulated handle prevented the basket from opening.Devices are inspected for functionality and damage during manufacturing and quality control checks.Devices are also packaged with the basket in the open position.It is likely the device was inadvertently damaged by the user during handling before use, preventing the basket from opening.The ifu contains a precaution to not use excessive force to manipulate this device or damage to the device may occur.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
Event or Problem Description
It is reported while preparing for an unspecified procedure using a ncompass nitinol tipless stone extractor, the user opened the package and it was immediately noted the device was broken and the basket was missing from the end.This device had no patient contact.A second basket was opened, and used to carry on with the intended procedure.No adverse effects to the patient have been reported as a result of this alleged product malfunction.The customer declined to answer any additional questions due to the fact that the device made no patient contact.

• Brand Name: NCOMPASS NITINOL TIPLESS STONE EXTRACTOR
• Common Device Name: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8608566
• Report Number: 1820334-2019-01049
• Device Sequence Number: 2011459
• Product Code: FFL
• UDI-Device Identifier: 00827002327016
• UDI-Public: (01)00827002327016(17)220102(10)9415288
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2022
• Device Model Number: G32701
• Device Catalogue Number: NCT4-024115
• Device Lot Number: 9415288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1