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

Model Number	G32863
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: other non-healthcare professional.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 or Problem Description
It was reported during an unspecified procedure using a ncompass nitinol tipless stone extractor, the basket would not close properly.The procedure was completed successfully with another device.The patient did not experience any adverse effects as a result of this alleged product malfunction.The patient did not require any additional procedures as a result of this occurrence.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.
Event or Problem Description
There is no new patient or event information to report.
Additional Manufacturer Narrative
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(ifu), sprcifications, and quality control data.The complainant returned two ncompass nitinol tipless stone extractors.The returned packaging confirms the reported lot number.Device a: device returned with the handle in the open position and the basket formation partially open.The basket formation width measures 5 mm.The mlla [male luer lock adapter] is loose.Th collet knob is tight and secure.Polyethylene terephtalate tubing [pett] measures 1.2 cm in length.Support sheath is partially severed 1 mm from mlla.The basket sheath is wavy in appearance.Function test determines the handle actuates the basket formation to the open position, but does not close completely without force.One wire in the basket formation is broken, no laser damage noted.Device b: device returned with the handle in the open position and the basket formation in the open position.The [male luer lock adapter] was loose.The collet knob was tight and secure.The polyethylene terephtalate tubing [pett] measures 1.5 cm in length.The basket sheath is severely bent at the base of the support sheath.There were kinks in the basket sheath located 17 cm from the distal tip and again at 19.5 cm and 66.5 cm from the distal tip of the basket sheath.A function test determined the handle does actuate the basket formation to the open position, but does not close completely.With the handle in the closed position, the basket sheath is severed 4 mm from the distal tip of the support sheath.With the handle in the open position, the coil protrudes from the basket sheath in a loop.The basket sheath is accordion near the separation.One wire in the basket formation has a pulled or stretched appearance.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history revealed no additional 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 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.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.Both devices were found to have baskets that would not fully close due to sheath damage.All devices are inspected for damage and functionality during production.It is likely there were factors related to the procedure that resulted in device damage.Either user technique or anatomical issues could have resulted in the observed damage.A definitive cause could not be determined.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.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: 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: 8760136
• Report Number: 1820334-2019-01614
• Device Sequence Number: 1488962
• Product Code: FFL
• UDI-Device Identifier: 00827002328631
• UDI-Public: (01)00827002328631(17)210912(10)9157002
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2019

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: 09/12/2021
• Device Model Number: G32863
• Device Catalogue Number: NCT4-024115-MB
• Device Lot Number: 9157002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1