MAUDE Adverse Event Report: COOK INC NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	G32724
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: cook district 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 or Problem Description
It is reported during an unspecified procedure using an ntrap stone entrapment and extraction device, the basket would not deploy (reported in mdr 1820334-2019-01335).A second similar device was opened from a different lot and the same difficulty occurred (refer to this report).A third device was opened and worked to complete the intended procedure successfully.No adverse to the patient have been reported as a result of this alleged product malfunction.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, manufacturing instructions, the instructions for use, and quality control data.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.Inspection of the returned device noted: two kinks in the basket sheath located 1.8 cm and 3.7 cm from distal tip of the basket sheath, the distance between the kinks is 2 cm.Functional testing noted 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.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions users should be familiar with and experienced in urological endoscopic surgery.Assess calculi or other foreign bodies prior to instrument deployment to ensure that object is not too large to be removed through the anatomy.If resistance is encountered while attempting to remove calculi or other foreign bodies, release the object.Do not exert excessive force on the device.Due to the asymmetric nature of the ntrap, do not torque or rotate the device in vivo.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 be non-functional.The basket was closed and could not be opened.The sheath of the device was damaged, being kinked in two locations near the distal end.The kinks were preventing the basket from opening.It appears the sheath of the device was inadvertently damaged during use, preventing the basket from opening.It appears the sheath of the device was inadvertently damaged during use, preventing the basket from opening.The ifu contains a precaution not to apply excessive force to the device.The first device used during the procedure that also experienced the same issue (reference 1820334-2019-01335), was found to be non-functional due to a damaged sheath.Since both device had similar damage, it was concluded the device was inadvertently damaged during use.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.The appropriate internal personnel have been notified and we will continue to monitor 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: NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE
• Common Device Name: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8701000
• Report Number: 1820334-2019-01395
• Device Sequence Number: 16636346
• Product Code: FFL
• UDI-Device Identifier: 00827002327245
• UDI-Public: (01)00827002327245(17)190613(10)7039607
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2019

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: 06/13/2019
• Device Model Number: G32724
• Device Catalogue Number: NTP-028145
• Device Lot Number: 7039607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1