MAUDE Adverse Event Report: COOK FLEXOR; URETERAL STENT, ENDOSCOPIC ACCESS

Model Number	G19168
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/05/2018
Event or Problem Description
Piece of sheath broke off inside of patient.Md able to retrieve.

• Brand Name: FLEXOR
• Common Device Name: URETERAL STENT, ENDOSCOPIC ACCESS
• Manufacturer (Section D): COOK
• MDR Report Key: 7193696
• Report Number: MW5074563
• Device Sequence Number: 16357153
• Product Code: FED
• UDI-Device Identifier: 00827002191686
• UDI-Public: (01)00827002191686(17)200907(10)
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/10/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: G19168
• Device Catalogue Number: 79217
• Device Lot Number: 8199569
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR