MAUDE Adverse Event Report: COOK INC ATLAS-WIRE STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	N/A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a unilateral rigid ureterorenal lithotripsy procedure, the tip of the extractor, located before the basket, was cracked.A new same type device was used to complete the procedure.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.There were no adverse effects on the patient due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(6).E3: occupation: quality coordinator.G4: 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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Correction: this report is being sent to indicate the complaint event is not reportable under fda 21 cfr part 803.As such, this event no longer meets the set criteria for a reportable event; no further reports regarding this event will be submitted.Investigation evaluation determined that the tip of the returned device was not found to be cracked.Could not confirm the reported issue.There is a point of compression approximately 1cm from distal end of sheath.This was likely the damage the customer reported as "tip of extractor cracked".Evaluation of the returned device has determined that the tip of the extractor, located before the basket, was not cracked as initially reported.Complaint was initially determined to be a reportable device malfunction based on the breakage of the basket formation or sheath.There is no evidence to suggest that the failure mode, compression in the basket sheath would be likely to cause or contribute to a death or a serious injury if the failure were to recur.Furthermore, there is no evidence that the device caused or contributed to a serious injury or patient death.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.

• Brand Name: ATLAS-WIRE STONE EXTRACTOR
• Common Device Name: 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: 17928203
• Report Number: 1820334-2023-01382
• Device Sequence Number: 17760345
• Product Code: FFL
• UDI-Device Identifier: 00827002328242
• UDI-Public: (01)00827002328242(17)251115(10)15071404
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2025
• Device Model Number: N/A
• Device Catalogue Number: AE-432115
• Device Lot Number: 15071404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female