FDA.reportPublic FDA data

MAUDE MDR 3824484

MDR report key
3824484
Report number
2951238-2014-00164
Event key
0
Event type
3
Date of event
2014-03-20
Date received
2014-04-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
NOEMI SCHAMBACH
Address
2400 RINGWOOD AVE. SAN JOSE CA 95131 US
Phone
408-408-4089
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PKS CUT FORCEPS, 5MM, 33CM, 9-PINFORCEPSGYRUS ACMI INCHFB920005PK920005PKUNKY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-04-039200051. R

Event Narratives#

D

Patient 1

THE USER FACILITY REPORTED THAT DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY THE PHYSICIAN WASN'T AWARE THAT THE DEVICE WAS INTERMITTENTLY COAGULATING AND WOULD CUT TISSUE AS THE PT HAD A VERY LARGE COAGULATION. THE PT LOST 100CC'S OF BLOOD FROM A BLEEDER AND HAD TO BE GIVEN A UNIT OF BLOOD FROM A BLEEDER AND HAD TO BE GIVEN A UNIT OF BLOOD. ANOTHER DEVICE WAS OPENED WHICH ALSO FAILED. THE CASE WAS FINISHED USING A THIRD DEVICE. OLYMPUS HAS ATTEMPTED TO FOLLOW UP TO OBTAIN FURTHER INFO REGARDING THE PT'S CONDITION BUT NO INFO HAS BEEN MADE AVAILABLE.

N

Patient 1

THE CUTTING FORCEPS WERE RETURNED TO OLYMPUS FOR EVALUATION. EVALUATION CONFIRMED THE COMPLAINT. VISUAL INSPECTION FOUND THE INSULATION DAMAGED ON ALL FOUR ELECTRODES AND THE FLARE CRACKED IN FOUR PLACES WHERE THE ELECTRODE HUMPS START TO ENTER THE SHAFT WHEN THE JAWS WERE CLOSED. THE JAWS OPEN/CLOSE, THE BLAD ADVANCES/RETRACTS AND THE LOCK FUNCTIONS AS DESIGNED. THE BARE SPORTS ON THE ELECTRODES WERE SHORTING CUT ON THE SHAFT WHERE THE FLARE WAS CRACKED. THE ROOT CAUSE WAS INCONCLUSIVE AND UNABLE TO BE DETERMINED. THE DEVICE HISTORY RECORD SHOWED NO DISCREPANCIES.