UROPASS AS 12/14FR X 46 CM 5/BX 61246BX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-02-13 for UROPASS AS 12/14FR X 46 CM 5/BX 61246BX manufactured by Teleflex Medical Oem.

Event Text Entries

[100134518] The device was not returned to olympus for evaluation. The exact cause of the reported event cannot be determined; however, based on similar reports the root cause for the reported event is substantial light exposure of the devices in the health care facility, which resulted in degradation and embrittlement of the dilator polymer.
Patient Sequence No: 1, Text Type: N, H10


[100134519] Olympus was informed that during an unspecified procedure, the ureteral access sheath tip broke off and fell inside the patient. The device fragment was retrieved. The intended procedure was completed with a similar device. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2951238-2018-00103
MDR Report Key7267447
Report SourceUSER FACILITY
Date Received2018-02-13
Date of Report2018-04-12
Date of Event2018-01-25
Date Mfgr Received2018-03-21
Device Manufacturer Date2014-12-01
Date Added to Maude2018-02-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CONNIE TUBERA
Manufacturer Street2400 RINGWOOD AVENUE
Manufacturer CitySAN JOSE CA 95131
Manufacturer CountryUS
Manufacturer Postal95131
Manufacturer Phone408935-512
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUROPASS AS 12/14FR X 46 CM 5/BX
Generic NameUROPASS AS 12/14FR X 46 CM 5/BX
Product CodeKNY
Date Received2018-02-13
Returned To Mfg2018-02-21
Model Number61246BX
Catalog Number61246BX
Lot Number09M1400189
ID NumberUDI
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL OEM
Manufacturer Address3750 ANNAPOLIS LANE NORTH, SUITE 160 PLYMOUTH MN 55447 US 55447


Patients

Patient NumberTreatmentOutcomeDate
10 2018-02-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.