FDA.reportPublic FDA data

MAUDE MDR 970624

MDR report key
970624
Report number
8010047-2007-00210
Event key
0
Event type
3
Date of event
2007-11-28
Date received
2007-12-28
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
LAURA STORMS-TYLER
Address
2400 RINGWOOD AVE. SAN JOSE CA 95131 US
Phone
484-484-4848
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OLYMPUSCOLONOSCOPEOLYMPUS MEDICAL SYSTEMS CORPORATIONFTJCF-H180ALNYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-12-280

Event Narratives#

D

Patient 1

THE USER FACILITY REPORTED THAT DURING A DIAGNOSTIC COLONOSCOPY, THEY EXPERIENCED A TOTAL LOSS OF VIDEO IMAGE. A NURSE AT THE FACILITY REPORTED THAT AT THE START OF THE PROCEDURE, THE VIDEO IMAGE FUNCTIONED APPROPRIATELY, BUT GRADUALLY CHANGED IN THE MIDDLE OF THE PROCEDURE. THE VIDEO IMAGE REPORTEDLY BECAME GRAINY, FOLLOWED BY HORIZONTAL LINES ON THE VIDEO MONITOR AND COMPUTER SCREEN, AND FINALLY THE VIDEO IMAGE WAS LOST. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SET OF EQUIPMENT IN ANOTHER PROCEDURE ROOM. THERE WAS NO PATIENT INJURY REPORTED.

N

Patient 1

THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE IMAGE FLICKERED AND BLACKED OUT WHEN MANIPULATING THE BENDING SECTION AREA. THE SHAPE OF THE BENDING SECTION WAS OBSERVED TO BE IRREGULAR WHEN ANGULATED IN THE UP DIRECTION DUE TO MULTIPLE BROKEN RINGS ON THE INTERIOR OF THE DEVICE. THE CHARGE COUPLED DEVICE (CCD) WIRES WERE FOUND TO BE CUT DUE TO THE BROKEN ANGLE WIRE RINGS, WHICH MOST LIKELY CAUSED OR CONTRIBUTED TO THE USER'S EXPERIENCE. THE BROKEN RINGS WERE DETERMINED TO BE DUE TO PHYSICAL DAMAGE TO THE ENDOSCOPE. THIS REPORT IS BEING FILED AS AN MDR IN AN ABUNDANCE OF CAUTION.