FDA.reportPublic FDA data

MAUDE MDR 6394186

MDR report key
6394186
Report number
8010047-2017-00277
Event key
0
Event type
3
Date of event
2017-02-09
Date received
2017-03-10
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#

Contact
MR HIROKI MORIYAMA
Address
2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8 JA
Phone
814-814-8142
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OES CHOLEDOCHOFIBERSCOPECHOLEDOCHO FIBERSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FBOCHF-P20R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-03-100

Event Narratives#

N

Patient 1

OLYMPUS HAS OBTAINED ADDITIONAL INFORMATION THAT THE USER FACILITY NORMALLY USES THE 3 MM SCOPE BUT IT WAS BEING REPAIRED, SO THE USER FACILITY USED THE SUBJECT DEVICE WHICH HAS 4.9 MM OUTER DIAMETER AT THE DISTAL END WITH A 5 MM CANNULA. AN AVAILABLE NEXT LARGER SIZE OF CANNULA WAS 12 MM AND REPORTEDLY IT WOULD BE TOO LARGE FOR THE PROCEDURE. THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. BUT RETURNED TO OLYMPUS KEYMED (OKM) FOR INVESTIGATION. THE INVESTIGATION FOUND THAT THERE WAS MECHANICAL DAMAGE AND WATER LEAKAGE. THE OUTER LAYER IN THE INSERTION UNIT OF THE SUBJECT DEVICE WAS FOUND TO BE DETACHED FROM THE INNER TUBE MECHANISM AND FOLDED. THE MANUFACTURING RECORD OF THE SUBJECT DEVICE WAS REVIEWED WITH NO IRREGULARITY RELATED TO THE PHENOMENON. THE SUBJECT DEVICE WAS LAST SERVICED ON (B)(6) 2016, AND THE INSERTION UNIT WAS REPLACED. THE EXACT CAUSE OF THE EVENT COULD NOT BE CONCLUDED AT THIS MOMENT BUT POSSIBILITY THE FOLLOWING COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR OF THE EVENT: CONCURRENT USE OF A CANNULA THAT COULD NOT KEEP SUFFICIENT CLEARANCE WITH THE SUBJECT DEVICE. IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

D

Patient 1

THE SUBJECT DEVICE WAS USED FOR A LAPAROSCOPIC COMMON BILE DUCT EXAMINATION. THE USER FACILITY REPORTED THAT THE DAMAGE IN INSERTION UNIT OF THE SUBJECT DEVICE THAT HAS 4.9 MM OUTER DIAMETER, WAS OBSERVED UPON WITHDRAWAL AND THE DAMAGE MAY HAVE OCCURRED AS A RESULT OF USING A CANNULA WHICH HAS 5 MM INNER DIAMETER. THE USER FACILITY ALSO REPORTED THAT A PORTION OF PLASTIC CAME OFF IN THE PATIENT?S ABDOMINAL CAVITY BUT IT WAS REMOVED. THE INTENDED PROCEDURE HAS BEEN COMPLETED.