FDA.reportPublic FDA data

MAUDE MDR 4006322

MDR report key
4006322
Report number
8010047-2014-00433
Event key
0
Event type
3
Date of event
2014-05-26
Date received
2014-08-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
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
1OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR VMECHANICAL LITHOTRIPTOROLYMPUS MEDICAL SYSTEMS CORPORATIONFEOBML-V242QR-30BML-V242QR-30UNKY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-08-0701. R

Event Narratives#

N

Patient 1

THE COIL SHEATH WAS RETURNED TO OMSC FOR INVESTIGATION. HOWEVER, WE COULDN'T CONFIRM THE BASKET WIRE SINCE IT WAS NOT RETURNED. THE INVESTIGATION CONFIRMED THAT THERE WERE MULTIPLE DEFORMATIONS ON THE COIL SHEATH. ACCORDING TO THE INVESTIGATION, OMSC CONSIDERS THAT THE CALCULUS WAS TOO HARD TO CRUSH AND IT CAUSED THIS EVENT. THE DEVICE INSTRUCTION MANUAL HAS WARNED USERS THAT THERE IS POSSIBILITY THE CALCULUS CANNOT BE CRUSHED BY LITHOTRIPTOR, AND IT IS ALSO DESCRIBES WHAT TO DO IF THE LITHOTRIPTOR CANNOT CRUSH THE CALCULUS. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

D

Patient 1

OLYMPUS MEDICAL SYSTEM CORP. (OMSC) WAS INFORMED THAT DURING CRUSHING CALCULUS WITH THE LITHOTRIPTER IN THE COMMON BILE DUCT, THE DOCTOR COULDN'T' CRUSH IT. HE COULDN'T WITHDRAW CALCULUS AND THE DEVICE FROM THE PATIENT. THE FACILITY CUT THE INSERTION PORTION OF THE DEVICE AND REMOVED THE SHEATH AND USED EMERGENCY HANDLE. HOWEVER, THEY APPREHENDED PERFORATION OF THE COMMON BILE DUCT AND DECIDED TO PERFORM OPEN SURGERY.