FDA.reportPublic FDA data

MAUDE MDR 9278133

MDR report key
9278133
Report number
1317056-2019-00143
Event key
0
Event type
3
Date of event
2019-10-15
Date received
2019-11-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LAW RYAN
Address
10 GLENS FALLS TECHNICAL PARK GLENS FALLS NY 12801 US
Phone
518-518-5187
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SOLERO MICROWAVE TISSUE ABLATION SYSTEMSYSTEM, ABLATION, MICROWAVE AND ACCESSORIESANGIODYNAMICSNEYH78712740000N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-0501. O

Event Narratives#

N

Patient 1

IT WAS REPORTED THAT THE SOLERO GENERATOR (SN (B)(4)) INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. TO DATE, THE GENERATOR HAS YET TO BE RETURNED. THE RESULTS OF THE UNIT EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. (B)(4).

D

Patient 1

AS REPORTED: SOLERO DISPLAYED ERROR CODE 209 WHEN THE PROBE WAS ATTACHED TO THE SOLERO. THEY POWERED THE UNIT DOWN PROBABLY 5 OR 6 TIMES, WAITED SEVERAL MINUTES EACH TIME AND POWERED IT BACK ON WITH THE SAME ERROR IMMEDIATELY DISPLAYING. THE PROCEDURE WAS NOT COMPLETED. AS THE PATIENT HAD BEEN UNNECESSARILY SEDATED (TREATMENT NOT PROVIDED), THIS EVENT MEETS THE CRITERIA OF REPORTABLE EVENT DUE TO PATIENT SAFETY RISK. IT WAS REPORTED THAT THE PATIENT SUFFERED NO ADVERSE EFFECTS DUE TO THE EVENT. AS A PRECAUTION, THE CUSTOMER HAS REQUESTED THE FACILITY'S UNIT BE EVALUATED BY THE MANUFACTURER. THE UNIT HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.