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

Catalog Number NTSE-022115-UDH

Device Problem Material Separation (1562)

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

Event Type  Injury  

Manufacturer Narrative

Occupation: other non-healthcare professional: or coordinator.Pma/510k # exempt.A follow up report will be submitted should additional relevant information become available.

Event Description

Aa reported, during a kidney stone extraction a ncircle tipless stone extractor basket tip broke off.The broken tip was retrieved using a grasper.It was noted that a laser had been used during the procedure.The procedure was ultimately completed in an unknown fashion.

Event Description

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

Manufacturer Narrative

Correction: h6 (annex g).Event summary: aa reported, during a kidney stone extraction a ncircle tipless stone extractor basket tip broke off.The broken tip was retrieved using a grasper.It was noted that a laser had been used during the procedure.The procedure was ultimately completed successfully.Investigation ¿ evaluation: a document-based investigation was performed including a review of complaint history, device history record (dhr), the instructions for use, manufacturing instructions, and quality control data.The device was not returned.A device was received from the same user and lot number with the same reported failure mode for manufacturer report #1820334-2022-00096.This device was returned in two pieces, with the basket assembly completely severed from the body of the basket.The wires forming the basket were also broken.A document-based investigation evaluation was performed.No related non-conformances were recorded.One additional complaint was reported for this lot number from the same user facility and same device issue.As a user-related issue was determined to be the cause of both events, a lot-related issue was not suspected.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.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precaution: the device is conductive.Avoid contact with any electrified instrument.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.The damage observed to the device returned for manufacturer report #1820334-2022-00096 indicates it was exposed to a large force.The cause for this event has been attributed to unintended user error, as force was likely inadvertently applied to the device during use.The ifu cautions that excessive force could damage the device.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: 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 ; 8128294891
• MDR Report Key: 13313893
• MDR Text Key: 284171881
• Report Number: 1820334-2022-00097
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002187785
• UDI-Public: (01)10827002187785(17)240726(10)14109413
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2024
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 14109413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 01/21/2022
• Supplement Dates Manufacturer Received: 03/16/2022
• Supplement Dates FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• 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
• Patient Outcome(s): Required Intervention