FDA.reportPublic FDA data

MAUDE MDR 124662

MDR report key
124662
Report number
MW1012235
Event key
0
Event type
3
Date of event
1997-09-29
Date received
1997-10-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KARL STORZHIGH FREQUENCY CORDKARL STORZ ENDOSCOPY-AMERICA, INC.FFZ26002M*AP03NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11997-10-0601. O

Event Narratives#

D

Patient 1

DURING A PELVISCOPY PROCEDURE, THE HIGH FREQUENCY CORD USED WITH THE MONOPOLAR ENDOSCOPIC INSTRUMENT CAUGHT ON FIRE AT THE JOINT BETWEEN THE CONNECTOR TO THE ESU AND THE CORD, SEVERING THE CORD INTO TWO PIECES. THE FIRE EXTINGUISHED ITSELF WHEN THE CORD WAS BURNT IN TWO. THIS WAS THE SECOND OCCURRENCE OF THE SAME EVENT WITH A DIFFERENT CORD.