POLYHESIVE RETURN ELECTRODE E7506

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-02-01 for POLYHESIVE RETURN ELECTRODE E7506 manufactured by Covidien Lp (valleylab).

Event Text Entries

[1317118] The customer reported that, following a radio frequency liver ablation using a boston scientific ablation generator and a e7506 non-rem pad, they discovered a pt injury. The grounding pads were placed in parallel at the top of the pt's thighs. The 5. 0cm probe was used and the algorithm for the 5. 0cm probe was followed. The grounding pads were checked every 4-5 minutes. Activation was approximately 42 minutes. When the grounding pads were removed a small area of erythema was present across the top of the legs and a 1 cm circumference skin break on the inside of the left thigh. Frozen saline was applied to the erythema and topical flamazine was used. The doctor expressed that he believes that the pads were to blame for the burn and that this is a risk of the procedure especially for longer activations with the 5cm probe. The four pads are on mfr report #s 1717344-2010-00006, 1717344-2010-00023 and 1717344-2010-00024.
Patient Sequence No: 1, Text Type: D, B5


[8430266] (b)(4). The pads were discarded and no evaluation can be performed. The ifu states: non-traditional procedures that utilize high current, long duty cycles, or both (for example: tissue lesioning, tissue ablation, tissue vaporization, and procedure in which conductive fluids such as saline or lactated ringer's solution are introduced into the surgical site for distention or to conduct the rf current) increase the risk of excessive heating under a fully applied return electrode to the point of injuring the pt. Use of more than one pt return electrode may help mitigate the increased risk.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1717344-2010-00022
MDR Report Key1600724
Report Source00
Date Received2010-02-01
Date of Report2010-01-04
Date of Event2009-11-17
Date Mfgr Received2010-01-04
Device Manufacturer Date2009-01-01
Date Added to Maude2010-09-15
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 FDA0
Event Location0
Manufacturer ContactKIM SCHWARZ, MGR
Manufacturer Street5920 LONGBOW DR.
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone3035306245
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePOLYHESIVE RETURN ELECTRODE
Generic NameELECTROSURGICAL ACCESSORY
Product CodeODR
Date Received2010-02-01
Catalog NumberE7506
Lot Number154945
Device Expiration Date2011-01-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN LP (VALLEYLAB)
Manufacturer Address5920 LONGBOW DR. BOULDER CO 80301 US 80301


Patients

Patient NumberTreatmentOutcomeDate
10 2010-02-01

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