MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UROPASS AS 11/13FR X 46 CM 5/BX

Model Number 61146BX

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2017

Event Type  malfunction  

Manufacturer Narrative

There was no record to indicate whether the device was returned to olympus for evaluation.The cause of the reported event could not be determined at this time.However, if additional information becomes available or if the device is returned for evaluation at a later date, this report will be supplemented accordingly.

Event Description

Olympus received a voluntary report (mw5071935) which states the tip at the distal end of the sheath split while performing a cysto-retrograde pyelogra.There was limited information regarding the reported event and the user facility/contact information was unidentified on the voluntary report.

Manufacturer Narrative

This supplemental report is being submitted to report additional information received from the original equipment manufacturer (oem).The device was not returned and no photo images were provided to olympus for evaluation.This device is manufactured by a vendor (teleflex).The oem performed a dhr review and revealed that the product met specifications at the time of manufacturing.

• Brand Name: UROPASS AS 11/13FR X 46 CM 5/BX
• Type of Device: UROPASS AS 11/13FR X 46 CM 5/BX
• Manufacturer (Section D): TELEFLEX MEDICAL OEM; 3750 annapolis lane north, suite 160; plymouth MN 55447
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6941194
• MDR Text Key: 90310540
• Report Number: 2951238-2017-00674
• 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: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 61146BX
• Device Catalogue Number: 61146BX
• Device Lot Number: 09F1600052
• Other Device ID Number: UDI
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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