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

Catalog Number NCT4-017115

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2020

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, during a stone removal procedure using a ncompass nitinol tipless stone extractor, the basket became unable to move.The user checked the device and discovered the orange protective sheath separated from the handle.Another same type device was used to complete the procedure.There have been no adverse effects to the patient reported due to the alleged malfunction.

Event Description

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

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, manufacturing instructions, drawing, and quality control data.One ncompass nitinol tipless stone extractor was returned for investigation.Inspection of the returned device noted 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) and collet knob were tight and secure.The polyethylene terephthalate tubing [pett] measured 2.5 cm in length.The support sheath was severed at the nose of the mlla.With the handle in the closed position, there were 2cm of the cannulated handle protruding from the mlla.There were kinks in the basket sheath at 88cm and 88.5 cm form the distal tip.Functional testing determined the handle does not actuate.A review of the device history record 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 closed and could not be opened due to sheath damage.The orange support sheath was separated at the handle, preventing the motion of the handle from functioning the basket.The provided information states the issue occurred during use.Possible causes for the separation of the orange support sheath are: variation in the manufacturing process that could have caused the support sheath to be abnormally weak.The support sheath could have been damaged from forces applied during handling/use.There is not enough information to determine a definitive 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.

• 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: 9621285
• MDR Text Key: 176052379
• Report Number: 1820334-2020-00186
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002460277
• UDI-Public: (01)10827002460277(17)220806(10)9930369
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

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: 08/06/2022
• Device Catalogue Number: NCT4-017115
• Device Lot Number: 9930369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 01/23/2020
• Supplement Dates Manufacturer Received: 02/14/2020
• Supplement Dates FDA Received: 02/19/2020
• Patient Sequence Number: 1