MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UROPASS AS 12/14FR X 24 CM 5/BX; URETERAL ACCESS SHEATH

Model Number 61224BX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Excessive Tear Production (2235)

Event Date 05/03/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the patient's outcome cannot be conclusively determined.Olympus followed up with the user facility to obtain additional information regarding the reported events by telephone and in writing but with no result.

Event Description

Olympus was informed that during a therapeutic ureteroscopy procedure, the uropass access sheath became stuck and upon removal the patient's ureter was torn.It was reported that the patient underwent open surgery to repair the ureter and the procedure was completed.

• Brand Name: UROPASS AS 12/14FR X 24 CM 5/BX
• Type of Device: URETERAL ACCESS SHEATH
• Manufacturer (Section D): TELEFLEX MEDICAL OEM; 3750 annapolis lane north, suite 160; plymouth 55447
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-516
• MDR Report Key: 5677151
• MDR Text Key: 45858250
• Report Number: 2951238-2016-00454
• Device Sequence Number: 1
• Product Code: KNY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 61224BX
• Device Catalogue Number: 61224BX
• Device Lot Number: UNKNOWN
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention