EPICOR ULTRACINCH LP ABLATION DEVICE UC-LP-10 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-09-15 for EPICOR ULTRACINCH LP ABLATION DEVICE UC-LP-10 * manufactured by St. Jude Medical.

Event Text Entries

[16037395] The epicor cinch was connected to the machine. During the self test, the screen displayed "4 damaged cells. " i disconnected the cinch and reconnected the cinch to machine. The machine performed another self test. Again the display read "4 damaged cells. " i turned the machine off, then repeated the process. After the damaged cells displayed the third time, we removed the cinch from the field and opened a new one. The new one worked. The damaged one was never used on the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1869375
MDR Report Key1869375
Date Received2010-09-15
Date of Report2010-09-15
Date of Event2010-08-28
Report Date2010-09-15
Date Reported to FDA2010-09-15
Date Added to Maude2010-10-14
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameEPICOR ULTRACINCH LP ABLATION DEVICE
Generic NameSYSTEM, ABLATION
Product CodeNTB
Date Received2010-09-15
Returned To Mfg2010-09-15
Model NumberUC-LP-10
Catalog Number*
Lot Number*
ID Number*
OperatorUNKNOWN
Device AvailabilityR
Device Age2 YR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL
Manufacturer Address240 SANTA ANA COURT SUNNYVALE CA 94085 US 94085


Patients

Patient NumberTreatmentOutcomeDate
10 2010-09-15

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