MRGFUS EXABLATE 2000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-09-24 for MRGFUS EXABLATE 2000 manufactured by Insightec, Ltd..

Event Text Entries

[4766747] A (b)(6) year old woman with adenomyosis and menometrorrhagia was "commercially" treated on (b)(6) with no remarkable events. In hr pas the patient underwent myomectomy by laparotomy and several ivf attempts. Three days post-treatment ((b)(6) 2014) the patient complaint of abdominal pain and was referred to the emergency room. She arrived to the er on (b)(6) 2014. Following deterioration of her condition, she was taken to emergency for a laparotomy. It was reported indirectly to insightec that at laparotomy feces was found in the abdominal cavity but no apparent perforation of perforation site was detected. The patient dies on (b)(6) 2014. On (b)(6) pm was performed. At this time, the pm results are not available, per hospital management decision. No other information is available at this time as well.
Patient Sequence No: 1, Text Type: D, B5


[12246258] Device has been diagnosed and found with no malfunctions. Site did not allow treatment review yet.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9615058-2014-00006
MDR Report Key4146933
Report Source01,07
Date Received2014-09-24
Date of Report2014-09-17
Date of Event2014-09-17
Date Mfgr Received2011-05-16
Device Manufacturer Date2009-08-01
Date Added to Maude2014-10-08
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 ContactORI LUBIN, MANAGER
Manufacturer Street5 NAHUM ST. PO BOX 2039
Manufacturer CityTIRAT CARMEL 31290
Manufacturer CountryIS
Manufacturer Postal31290
Manufacturer Phone54488199
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMRGFUS EXABLATE
Generic NameHIFU
Product CodeNRZ
Date Received2014-09-24
Model Number2000
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerINSIGHTEC, LTD.
Manufacturer Address5 NAHUM ST. TIRAT CARMEL 3912001 IS 3912001


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2014-09-24

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