IGLESIAS WORKING ELEMENT EIWE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-07-24 for IGLESIAS WORKING ELEMENT EIWE manufactured by Gyrus Acmi, Inc.

Event Text Entries

[80946213] The device was not returned to olympus for evaluation. The cause of the reported event cannot be determined at this time.
Patient Sequence No: 1, Text Type: N, H10


[80946214] Olympus was informed that during transurethral resection of bladder tumor (turbt) procedure, the surgeon observed the active cord melting and smoking with sizzling and popping sounds coming at the connection of the working element. It was reported that there was no sparking or arching observed. The procedure was completed with a similar device. There was no patient injury reported. This is report 2 of 2.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2951238-2017-00485
MDR Report Key6739143
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2017-07-24
Date of Report2017-07-24
Date of Event2017-02-06
Date Mfgr Received2017-07-14
Date Added to Maude2017-07-24
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 NameIGLESIAS WORKING ELEMENT
Generic NameIGLESIAS WORKING ELEMENT
Product CodeFBO
Date Received2017-07-24
Model NumberEIWE
Catalog NumberEIWE
Lot NumberUNKNOWN
ID NumberUDI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGYRUS ACMI, INC
Manufacturer Address136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772


Patients

Patient NumberTreatmentOutcomeDate
10 2017-07-24

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