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

Catalog Number NTSE-022115-UDH

Device Problem Break (1069)

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

Event Date 07/06/2022

Event Type  malfunction  

Event Description

As reported, prior to a stone extraction, an ncircle tipless stone extractor broke through the "plastic handle portion where there is no sheath." the wire protruded through the separation, and the basket would not function due to the damage.This was noted upon opening the packaging.The device did not make patient contact.A new same-type device was used to complete the procedure successfully.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to the occurrence.According to the initial reporter, the patient did not experience any adverse effects.Upon return and initial evaluation of the device, the basket sheath was separated, and the inner basket wire protruded through the separation.

Manufacturer Narrative

Occupation: surgery strategic buyer/supply chain manager.Pma/510(k) #: exempt.Device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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.

Manufacturer Narrative

Summary of event: as reported, prior to a stone extraction, an ncircle tipless stone extractor broke through the "plastic handle portion where there is no sheath." the wire protruded through the separation, and the basket would not function due to the damage.This was noted upon opening the packaging.The device did not make patient contact.A new same-type device was used to complete the procedure successfully.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to the occurrence.According to the initial reporter, the patient did not experience any adverse effects.Investigation evaluation: reviews of the instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection and functional test of the returned complaint device was also conducted.The complaint device was returned without any packaging or a label.A small loop of the inner basket wire had come through the sheath.When the basket was in the open position, the loop was present.When the basket was in the closed position, the loop was not present.There was a small kink in the basket sheath approximately 2 centimeters from the distal end.Cook could not complete a review of the device history record or complaint history due to lack of lot information from the user facility.A review of relevant manufacturing and quality control documents was conducted.All extractors are verified to assure the basket opens and closes properly.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu) does not provide any information related to the reported issue.The information provided upon review of complaint file and quality control documents provide evidence to support that the device was manufactured to specification.The returned device was found to have a basket that would not open/close due to the sheath damage.The basket sheath was separated, preventing the basket from functioning.Cook has concluded that the cause for the observed sheath damage could not be determined.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: NCIRCLE 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: 15084236
• MDR Text Key: 304436104
• Report Number: 1820334-2022-01257
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2022
• 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