FDA.reportPublic FDA data

MAUDE MDR 334252

MDR report key
334252
Report number
1038548-2001-00026
Event key
0
Event type
3
Date received
2001-05-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
KRISTEN PIATAK
Address
5175 SOUTH ROYAL ATLANTA DRIVE TUCKER GA 30084 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1REUSABLE SWITCH-BLADE SHAFT, 32CMELECTROSURGICAL DEVICEGENZYME SURGICAL PRODUCTS CORP.GEINA90-1050UNKK930666NYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-05-2301. O

Event Narratives#

D

Patient 1

THE REPORTER ALLEGED THAT OVER A PERIOD OF FIVE MONTHS THERE HAVE BEEN THREE OR FOUR CASES OF TISSUE BURNS WHILE USING THE SWITCHBLADE SCISSOR. THE DOCTOR WAS CONTACTED FOR INFORMATION. PER THE PHYSICIAN, THE CASES WERE ALL LAPARASCOPIC DONOR NEPHRECTOMY OPERATIONS. FOR THREE OF THE CASES, AS THE KIDNEY WAS DISSECTED, LITTLE BURNS WERE NOTED AROUND THE COLON DURING THE PROCEDURE. THE DOCTOR STATED THE BURNS WERE REASONABLY SUPERFICIAL AND THE PATIENT WAS NOT INJURED. THE PATIENTS HAVE HEALED AND ARE DOING FINE.