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

Catalog Number NCT4-017115

Device Problems Deformation Due to Compressive Stress (2889); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation- or manager.Pma/510(k) #- exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, prior to a ureteroscopy, two ngage nitinol stone extractors (patient identifier (b)(6)) and two ncompass nitinol tipless stone extractors were kinked between the basket sheath and basket wire.The devices could not be opened and closed.The devices did not make patient contact.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional event information has been requested.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Corrected information: h6:component code (annex g) event description: as reported, prior to a ureteroscopy, two ngage nitinol stone extractors (patient identifier (b)(6)) and two ncompass nitinol tipless stone extractors were kinked between the basket sheath and basket wire.The devices could not be opened and closed.The devices did not make patient contact.The patient reportedly experienced no harm as a result of the issue.Investigation - evaluation reviews of instructions, instructions for use (ifu), manufacturing instructions, and quality control data were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A picture was provided that showed the basket sheath was kinked/bent at the support sheath.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.A review of the device history record could not be completed due to lack of lot information from the user facility.A review of complaint history records could not be completed due to lack of lot information from the user facility.The information provided upon review of complaint file and quality control documents did not provide evidence to support that the device was manufactured out of specification or to suggest similar devices in the field or in house were nonconforming.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 picture of one device was provided.The picture showed that the basket sheath was kinked at the support sheath.It was assumed all 4 devices had the same issue.Devices are inspected for functionality and damage during quality control checks.The kink shown in the provided picture would have prevented the device from fitting into the shipping tray.It is likely the devices were inadvertently damaged by the user when removing them from the package, or during subsequent handling.Per the quality engineering risk assessment, no further action is required.The appropriate 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 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information was received 25feb2022: as reported, the devices were used in different procedures.It is unknown how many procedures.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.A visual inspection and functional testing of the returned device was conducted.One ncompass nitinol tipless stone extractor was returned in a clear bag on the tray.The white knob is completely loose and almost off the threads.The black knob is tight and the spacer was present.The handle did not actuate basket formation.Once the black knob was loosened a segment of the stiff wire portion of the basket assembly fell out.The basket sheath was kinked 90 degrees at the orange support sheath.The device was disassembled during the investigation and the cannulated handle was found to be separated.The returned device was found to be non-functional due to sheath damage.Based on the condition of the returned device, the sheath was bent when the basket was in the open position, which would have kinked the sheath and bent the cannulated handle in the same position.The most likely cause for the observed damage was that excessive force was applied to the device.Per the quality engineering risk assessment, no further action is required.The appropriate 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 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12933705
• MDR Text Key: 285802892
• Report Number: 1820334-2021-02635
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NCT4-017115
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1