FDA.reportPublic FDA data

MAUDE MDR 1582691

MDR report key
1582691
Report number
9610617-2009-00040
Event key
0
Event type
3
Date of event
2009-08-06
Date received
2009-12-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
MITTELSTRASSE 8 POSTFACH 230 TUTTLINGEN 78503 GM
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KARL STORZESOPHAGOSCOPEKARL STORZ GMBH & CO. KGEOX12060C12060CDBY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-12-3101. O

Event Narratives#

D

Patient 1

ALLEGEDLY, DURING AN ESOPHAGOSCOPY THE PT'S ESOPHAGUS WAS PERFORATED; THE PERFORATION WAS REPAIRED AND PT WAS RELEASED AFTER ONE WEEK IN HOSPITAL AFTER DOCTOR CONFIRMED AREA HEALED. LATER, THE PT RETURNED TO THE HOSPITAL AND IT WAS FOUND THAT THE REPAIR HAD BROKEN. DOCTOR REPAIRED AGAIN.

N

Patient 1

THE 12060C WAS EXAMINED AND FOUND TO BE IN GOOD WORKING CONDITION AND WITHIN SPECIFICATIONS. THERE WAS NO DAMAGE NOTED ON PRODUCT.