FDA.reportPublic FDA data

MAUDE MDR 1078558

MDR report key
1078558
Report number
3004082685-2008-00002
Event key
0
Event type
3
Date of event
2008-06-17
Date received
2008-07-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
STEPHEN SOLOMON
Address
220 S. ORANGE AVE. LIVINGSTON NJ 07039 US
Phone
973-973-9735
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THE WANDHANDPIECEMILESTONE SCIENTIFICEJIWA-2050-301NA061109NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-07-1801. R

Event Narratives#

D

Patient 1

A WAND HANDPIECE WITH A BONDED 30-GAUGE 1" NEEDLE WAS USED TO PERFORM A DENTAL INJECTION. THE USER ASSEMBLED THE HANDPIECE AND ATTACHED IT TO THE DRIVE UNIT. THE USER ACKNOWLEDGED "BENDING" THE NEEDLE PRIOR TO THE PLACING THE NEEDLE TO PERFORMING THE INJECTION. THE INJECTION WAS SUCCESSFUL. UPON REMOVAL OF THE HANDPIECE FROM THE PATIENT'S MOUTH, THE NEEDLE SEPARATED AT THE NEEDLE/HUB INTERFACE. USER CONFIRMED THE LOCATION OF THE NEEDLE FRAGMENT WITHIN THE SOFT TISSUE AND REMOVED IT WITHOUT INJURY TO THE PATIENT.

N

Patient 1

IN THE OPERATORS MANUAL UNDER BASIC OPERATION, IT RECOMMENDS THAT THE OPERATOR BEND THE HANDPIECE AND NOT THE NEEDLE. THE OPERATOR FAILED TO FOLLOW THESE INSTRUCTIONS AND BENT THE NEEDLE. THE OPERATOR DISPOSED OF THE HANDPIECE IN QUESTION AND WE WERE, THEREFORE, UNABLE TO CONDUCT ANALYSIS ON THAT DEVICE. SIMILAR HANDPIECES FROM THE SAME LOT NUMBER WERE REVIEWED AND THE NEEDLES WERE INTACT AND BONDED PROPERLY TO THE HUB. TESTS SHOWED THAT BENDING THE HANDPIECES COULD CAUSE THEM TO BREAK. NO ACTION BY THE MANUFACTURER IS PLANNED AT THIS TIME.