MAUDE Adverse Event Report: COOK INC UNIVERSA SOFT URETERAL STENT SET; FAD STENT, URETERAL

Model Number	G49940
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
As reported, upon opening a universa soft ureteral stent set, the stent was broken into 2 pieces.A new same type device was used to complete the ureterorenoscopy.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures.According to the initial reporter, the patient did not experience any adverse effects due to the occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event description: as reported, upon opening a universa soft ureteral stent set, the stent was broken into 2 pieces.A new same type device was used to complete the ureterorenoscopy.A section of the device did not remain inside the patients body.The patient did not require any additional procedures.According to the initial reporter, the patient did not experience any adverse effects due to the occurrence.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record (dhr), manufacturing instructions, the instructions for use (ifu), manufacturing instructions, and quality control procedures.One universa soft ureteral stent set was returned for investigation in open packaging.The tether was still attached.The stent was torn at the untethered end.The tear appears rough, and is not associated with a sideport.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.The information provided upon review of complaint file, device history record, complaint history and quality control documents did not provide evidence to support that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house were nonconforming.A review of relevant manufacturing and quality control documents was conducted.It was concluded that the stent shape was adequately inspected during quality control.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied upon removal from package, inspect the product to ensure no damage has occurred.Based on the available information, cook has concluded that a cause for this event could not be determined.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• 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: 14556994
• Report Number: 1820334-2022-00983
• Device Sequence Number: 20123066
• Product Code: FAD
• UDI-Device Identifier: 00827002499409
• UDI-Public: (01)00827002499409(17)230324(10)13076123
• Combination Product (Y/N): N
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2022

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: 03/24/2023
• Device Model Number: G49940
• Device Catalogue Number: USH-622
• Device Lot Number: 13076123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2020
• 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: Male