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

Model Number	G49934
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Occupation: prosthesis manager.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It is reported during a robotic assisted diverticulectomy using a universa soft ureteral stent set, the end of the stent was shredded and unable to be used.This was discovered prior to the device making contact with the patient.It is unknown how the procedure was completed after the difficulty.The patient experienced no adverse effects as a result of this alleged product malfunction.The patient did not require any additional procedures due to this occurrence.Additional details regarding the patient and the event have been requested.At this time, no additional information has been provided.
Additional Manufacturer Narrative
H6: device code: appropriate term/code not available (4247): per customer-then end of the stent was shredded and could not be used.Investigation ¿ evaluation.The complaint device was not returned, therefore visual examination and functional testing could not be performed.A document based investigation was performed including a review of specifications and quality control data.A device history record review was completed and it was concluded that there are no related non-conformances.A review of complaints showed no other complaints related to this lot.Conclusion: the cause of the complaint has not been established.A review of the device history record did not identify any related anomalies and no other complaints have been reported for this lot at the time of this investigation.The complaint device was not returned for evaluation.The risk analysis was conducted and concluded no additional risk reduction was required.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.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
There is no new patient or event information to report.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8682597
• Report Number: 1820334-2019-01358
• Device Sequence Number: 2292784
• Product Code: FAD
• UDI-Device Identifier: 00827002499348
• UDI-Public: (01)00827002499348(17)220320(10)9606667
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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: 03/20/2022
• Device Model Number: G49934
• Device Catalogue Number: USH-526
• Device Lot Number: 9606667
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1