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

Catalog Number NCT4-017115

Device Problem Material Twisted/Bent (2981)

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

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

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 Description

As reported, during an unspecified procedure, two ncompass nitinol tipless stone extractors had issues where the baskets kinked/separated at the shaft where the basket handle connects to shaft.No adverse events have been reported as a result of the alleged malfunction.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Event Description

Additional information was received 12oct2021: as reported, the procedure being performed was a ureteroscopy with laser lithotripsy.The devices were tested to determine if the baskets opened/closed prior to being used.A new basket was used to complete the procedure.No section of the device remained inside the patient's body.The patient was not hospitalized and there was no prolonged hospitalization due to this occurrence.The patient did not require any additional procedures due to this occurrence.The patient did not experience any harm due to this occurrence.

Manufacturer Narrative

E3: occupation: urology clinician.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

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an unspecified procedure, two ncompass nitinol tipless stone extractors had issues where the baskets kinked/separated at the shaft where the basket handle connects to shaft.The procedure being performed was a ureteroscopy with laser lithotripsy.The devices were tested to determine if the baskets opened/closed prior to being used.A new basket was used to complete the procedure.No adverse events have been reported as a result of the alleged malfunction.No section of the device remained inside the patient's body.The patient was not hospitalized and there was no prolonged hospitalization due to this occurrence.The patient did not require any additional procedures due to this occurrence.The patient did not experience any harm due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigaiton.A visual and functional test of the complaint device was also conducted.Both devices were returned to cook without packaging.Both devices have broken support sheaths.In response to this incident, cook completed a review of the device history record (dhr).Cook concluded that there are no non-conformances related to this incident.A lot history search found no other complaints have been reported for this lot.Because there were no related non-conformances, adequate inspection activities had been established, there was objective evidence that the dhr was fully executed, and no other lot related complaints had been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The product specification for the ncompass nitinol tipless stone extractor (b)(6) was reviewed and all extractors are 100% 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.Cook also reviewed the product labeling.The instructions for use (ifu) provides the following 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.Two devices were returned and both were found to have the orange support sheath separated at the handle.Provided information stated "upon following up with the staff it was determined to be user error and addressed with the physician." based on the provided information and investigation of the returned devices, the cause was determined to be an inadvertent user error in that excessive force was applied to the devices.The ifu supplied with the devices contains a precaution to not use excessive force to manipulate the device or damage to the device may occur.The risk analysis for this failure mode was reviewed and no additional escalation was required.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 new patient or event information to report since the previous medwatch report was submitted.

• 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: 12455404
• MDR Text Key: 270906230
• Report Number: 1820334-2021-02136
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002460277
• UDI-Public: (01)10827002460277(17)230818(10)13375339
• 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,Followup
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2023
• Device Catalogue Number: NCT4-017115
• Device Lot Number: 13375339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2020
• 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