FDA.reportPublic FDA data

MAUDE MDR 633328

MDR report key
633328
Report number
2020550-2005-00017
Event key
0
Event type
3
Date of event
2005-07-22
Date received
2005-09-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KARL STORZ ENDOVISIONLIGHT CABLEKARL STORZFFZ495NCS495NCSUNKNN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-09-0201. O

Event Narratives#

D

Patient 1

PATIENT UNDERWNET A CYSTO-URETEROSCOPY PROCEDURE. AFTER THE PROCEDURE, DURING RECOVERY, THE PT COMPLAINED ABOUT PAIN ON THEIR HAND AND AT THAT TIME A BURN ON THE PT'S RIGHT HAND IN THE AREA BETWEEN THE INDEX FINGER AND THUMB WAS OBSERVED. A PLASTIC SURGEON WAS CALLED TO EXAMINE IT AND A SURGERY TO REMOVE THE BURNED SKIN WAS DONE IN 07/05 AND THE PT WAS DISCHARGED THE NEXT DAY. THE HOSPITAL SUSPECTS THE BURN WAS CAUSED AS RESULT OF THE LIGHT CABLE BEING DETACHED FROM THE TELESCOPE, THEN LAID ACROSS THE PT'S CHEST AND LEFT ON THE HAND.