UROPASS AS 10/12FR X 38 CM 5/BX 61038BX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-29 for UROPASS AS 10/12FR X 38 CM 5/BX 61038BX manufactured by Teleflex Medical Oem.

Event Text Entries

[109641979] At the time of this report, the device has not yet been returned for evaluation. As a result, a determination cannot be made at this time. If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly. Device not yet returned.
Patient Sequence No: 1, Text Type: N, H10


[109641980] Olympus access sheath (10/12 x 38cm) ref no. 61038bx lot no. 09b1800252 was inserted by surgeon into ureter. He then inserted a flexible ureteroscope, pulled out but on the second time he tried to insert, there was a resistance and when he checked the sheath was broken.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005975494-2018-00007
MDR Report Key7549906
Date Received2018-05-29
Date of Report2018-09-10
Date of Event2018-04-25
Date Mfgr Received2018-09-04
Date Added to Maude2018-05-29
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 ContactMR TERRENCE SULLIVAN
Manufacturer Street136 TURNPIKE ROAD
Manufacturer CitySOUTHBOROUGH MA 01772
Manufacturer CountryUS
Manufacturer Postal01772
Manufacturer Phone5088042739
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUROPASS AS 10/12FR X 38 CM 5/BX
Generic NameACCESS SHEATH
Product CodeKYN
Date Received2018-05-29
Model Number61038BX
Lot Number09B1800252
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
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 2018-05-29

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