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

Catalog Number NTSE-022115-UDH

Device Problems Break (1069); Difficult to Open or Close (2921)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

As reported, the physician went to use an ncircle tipless stone extractor and found it was broken.There were no adverse effects to the patient reported.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Pma/510k # exempt.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.

Event Description

Additional information received 22mar2023: the procedure being performed was a left ureteroscopy and stone removal.The device was tested prior to use and was not used on the patient.When the customer went to use it the pin that holds the opening and closing of the mechanism was not present.The device would not open or close.The procedure was completed with another device of the same type.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

B5 = additional information received 22mar2023.H3 = device evaluated by mfg = other (81) - 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 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.

Manufacturer Narrative

Event description: as reported, the physician found an ncircle tipless stone extractor was broken prior to a left ureteroscopy and stone removal procedure.The device was not used on the patient.When the customer went to use it the pin that holds the opening and closing of the mechanism was not present.The device would not open or close.The procedure was completed with another device of the same type.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.Investigation evaluation: a document based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control procedures, as well as a visual inspection and functional test of the returned device were conducted during the investigation.One device was returned to cook with original pouch for investigation.The handle was in open position with the basket open and the support sheath was slightly bowed.When in the open position, the basket was overextended.The handle actuated the basket, but the basket did not close completely.The handle was disassembled, and the basket could be manually functioned.Reassembled handle-handle actuates basket formation to open and closed positions.A document-based investigation evaluation was performed.No related non-conformances were recorded.No additional complaints were received for this product lot.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.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.Sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed product labeling.The product ifu did not provide any information related to the reported issue.Based on the information provided, inspection of the returned device, and the results of the investigation, the cause for the issue could not be conclusively determined.The bent support sheath may indicate the device suffered slight damage during handling before use.However, there was no information known related to device handling.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, 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.

• 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: 16582855
• MDR Text Key: 312288962
• Report Number: 1820334-2023-00277
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002187785
• UDI-Public: (01)10827002187785(17)250603(10)14770337
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2023

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 Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 14770337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 03/22/2023; 04/21/2023
• Supplement Dates FDA Received: 04/20/2023; 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2022
• 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