VERSAPORT UNVCA12STF

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for VERSAPORT UNVCA12STF manufactured by Davis & Geck Caribe Ltd.

Event Text Entries

[185770250] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185770251] According to the reporter, during laparoscopic right inguinal hernia surgery, when instrument was inserted, trocar valve was pierced and it leaked. The reported device was still used to continue the case. The surgical time was extended by thirty minutes or more and incision was extended due to the product problem. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612501-2020-00558
MDR Report Key9901880
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-11
Date Mfgr Received2020-03-11
Device Manufacturer Date2018-05-22
Date Added to Maude2020-03-30
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 ContactLISA HERNANDEZ
Manufacturer Street60 MIDDLETOWN AVE.
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925563
Manufacturer G1DAVIS & GECK CARIBE LTD
Manufacturer StreetZONA FRANCA DE SAN ISIDRO
Manufacturer CitySANTO DOMINGO 0101
Manufacturer CountryDO
Manufacturer Postal Code0101
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVERSAPORT
Generic NameLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Product CodeGCJ
Date Received2020-03-30
Model NumberUNVCA12STF
Catalog NumberUNVCA12STF
Lot NumberJ8E1722X
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDAVIS & GECK CARIBE LTD
Manufacturer AddressZONA FRANCA DE SAN ISIDRO SANTO DOMINGO 0101 DO 0101


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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