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MAUDE MDR 5852998

MDR report key
5852998
Report number
MW5063880
Event key
0
Event type
3
Date of event
2016-07-29
Date received
2016-08-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GS2000 INSUFFLATORGS2000 INSUFFLATORCONMED CORPORATIONFCX50L INSUFFLATORGS2000* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-08-0301. R

Event Narratives#

D

Patient 1

THE PNEUMOPERITONEUM WAS THEN HOOKED UP THROUGH THE PORT. IN THE USUAL FASHION WE ATTEMPTED TO INSUFFLATE THE ABDOMEN TO 15 MMHG, WHICH THE SETTINGS WERE CONFIRMED ON INSUFFLATION MACHINE. HER ABDOMEN BECAME DISTENDED AND WE NOTICED AFTER A FEW SECONDS THAT IT WAS OVER DISTENDED AND THAT WE WERE HAVING DIFFICULTY VENTILATING THE PT ALL OF A SUDDEN. THE ABDOMEN WAS VERY RIGID. AFTER A FEW SECONDS, WE EVACUATED THE PNEUMOPERITONEUM. THE INSUFFLATION WAS STOPPED. AT THIS POINT WE REALIZED THAT THE INSUFFLATOR HAD MALFUNCTIONED AND THE PT HAD RECEIVED A GREATER THAN DESIRED AMOUNT OF CO2 TO THE ABDOMEN AND THERE HAD BEEN EXTRAVASATION OF THE CO2 INTO HER TISSUE PLANES ON HER CHEST WALL, UP INTO HER SCALP, FACE CAUSING CREPITUS THROUGHOUT. (B)(4).