FDA.reportPublic FDA data

MAUDE MDR 318143

MDR report key
318143
Report number
1038548-2001-00012
Event key
0
Event type
3
Date received
2001-03-02
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
PETE STEGAGNO
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
1DAIMOND-FLEX 80MM ANGLED TRIANGULAR RETRACTORRETRACTORGENZYME BIOSURGERYGADNA89-6112J99K946239NYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-03-0201. O

Event Narratives#

D

Patient 1

THE REPORTER STATED THAT THE DISTAL END IS NOT RIGID ENOUGH AND TENDS TO DAMAGE THE LIVER. FURTHER INFO REVEALED THAT DURING A PROCEDURE, THE LIVER TISSUE WAS "PINCHED" OR "SCRATCHED". THE REPORTER NOTED THAT SEGMENTS ON THE RIGHT SIDE OF THE SHAPE FORMATION APPEARED WIDER THAN USUAL. THE PT DID NOT SUSTAIN AN INJURY AND AN INCIDENT REPORT WAS NOT FILED AT THE FACILITY.