VOLUSON P8 UKVP8B

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-24 for VOLUSON P8 UKVP8B manufactured by Ge Ultrasound Korea, Ltd..

Event Text Entries

[146117253] (b)(4). Ge's investigation has completed and concluded the adverse event was the result of an inherent risk of the procedure.
Patient Sequence No: 1, Text Type: N, H10


[146117254] It was reported that two patients each were injured on separate dates. This report represents the first patient injury, patient (b)(6). The voluson p8 was used for ultrasound biopsy needle guidance during vivo oocyte retrieval (vor). The ultrasound probe used was an ic9-rs probe (s/n (b)(4)) along with a cook medical immature ovum aspiration needle (g44358) for harvesting oocytes. The patient went home, and later in the day went to an operation room for operative laparoscopy and cauterization.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9710090-2019-00002
MDR Report Key8642032
Report SourceUSER FACILITY
Date Received2019-05-24
Date of Report2019-05-24
Date of Event2019-01-22
Date Mfgr Received2019-05-14
Device Manufacturer Date2018-10-16
Date Added to Maude2019-05-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJOSEPH TAMBLYN
Manufacturer Street9900 W INNOVATION DR MAIL DROP: RP-2130 / B4422
Manufacturer CityWAUWATOSA WI
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVOLUSON P8
Generic NameDIAGNOSTIC ULTRASOUND IMAGING SYSTEM
Product CodeIYN
Date Received2019-05-24
Model NumberUKVP8B
Lot NumberVP8801216
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerGE ULTRASOUND KOREA, LTD.
Manufacturer AddressSEEH10 SEONGNAM-SI 462-807 KS 462-807


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-05-24

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