FDA.reportPublic FDA data

MAUDE MDR 3931343

MDR report key
3931343
Report number
8010047-2014-00169
Event key
0
Event type
3
Date of event
2014-03-28
Date received
2014-04-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
HIROKI MORIYAMA
Address
2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8 JA
Phone
264-264-2642
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LOOP CUTTERLOOP CUTTEROLYMPUS MEDICAL SYSTEMS CORPORATIONHINFS-5L-1NAK2Y30-0154Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-04-040

Event Narratives#

D

Patient 1

OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT THE DOCTOR ATTEMPTED TO PLACE AN ESOPHAGEAL STENT MANUFACTURED BY (B)(4) TO THE PATIENT AND CUT ITS BAND USING THE SUBJECT DEVICE. THEN THE BAND WAS STUCK IN THE CUTTER AND THE DOCTOR COULD NOT TEMPORARILY WITHDRAW THE DEVICE FROM THE PATIENT. THE DOCTOR BURNED OFF THE BAND WITH A LASER AND WITHDREW THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT INJURY REGARDING THIS REPORT.

N

Patient 1

THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR INVESTIGATION, THE INVESTIGATION CONFIRMED THAT THE BAND WAS STUCK IN THE CUTTER PART. WHEN REMOVING IT FROM CUTTER PART, THE CUTTER OPENED AND CLOSED SMOOTHLY. THE CUTTER WAS NOT DEFORMED AND AS THE RESULT OF CHECKING THE MANUFACTURING RECORD OF THE SAME LOT, NOTHING ABNORMAL WAS DETECTED. THUS, OMSC CONSIDERS THAT CUTTING THE BAND OF THE STENT CAUSED THIS EVENT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.