FDA.reportPublic FDA data

MAUDE MDR 1736517

MDR report key
1736517
Report number
9610617-2010-00012
Event key
0
Event type
3
Date of event
2010-04-30
Date received
2010-06-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
MITTELSTRASSE 8 POSTFACH 230 TUTTLINGEN GM
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KARL STORZRIGID SCOPEKARL STORZ GMBH & CO. KGFBP26003BA26003BANAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-06-090

Event Narratives#

D

Patient 1

ALLEGEDLY, DURING A COLORECTAL PROCEDURE, DOCTOR LAID SCOPE ATTACHED TO LIGHT CABLE ON PT; ACTIVE LIGHT SOURCE WAS NOT PUT ON STANDBY AND THE TIP OF SCOPE MADE A SMALL BURN TO THE DRAPE. DOCTOR IMMEDIATELY NOTICE AND REMOVED SCOPE; THERE WAS NO PT IMPACT. PROCEDURE WAS COMPLETED.

N

Patient 1

FOUND THE SCOPE TO HAVE SIGNS OF CUSTOMER USAGE/DAMAGE. SCOPE FAILED LEAK TEST. ALSO FOUND ABRASIONS AND NICKS ON BLOCK, SHAFT AND TINY TOOL MARKS ON TAPER AND POST SIDE. THE SCOPE, LIGHT CABLE AND LIGHT SOURCE WERE ALL TESTED TOGETHER AND FOUND TO FUNCTION WITHIN SPECIFICATIONS. NONE OF THESE FINDINGS ARE RELEVANT TO THE EVENT REPORTED; THE REASON DRAPE BURNED WAS BECAUSE USER LAID SCOPE WITH ACTIVE LIGHT SOURCE ON DRAPE WITHOUT SELECTING STANDBY FUNCTION. NO PT IMPACT.