FDA.reportPublic FDA data

MAUDE MDR 4602794

MDR report key
4602794
Report number
1064371-2015-00001
Event key
0
Event type
3
Date of event
2015-02-05
Date received
2015-03-09
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
BRUCE BECKSTEIN
Address
670 TALLEVAST ROAD SARASOTA FL 34243 US
Phone
866-866-8666
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MEDONE SURGICAL, INC.OPHTHALMIC CANNULAMEDONE SURGICAL, INC.NGYJ1425R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-03-090

Event Narratives#

D

Patient 1

TIP DETACHED FROM CANNULA DURING SURGERY. CANNULA WAS BEING USED FOR FLUID EXTRACTION DURING VITRECTOMY PROCEDURE. DURING THE CASE, THE SURGEON NOTICED THAT THE CLEAR FLEX TIP DETACHED FROM THE CANNULA. SURGEON'S FELLOW WAS ABLE TO GRASP THE FLEX TIP WITH FORCEPS AND ATTEMPTED TO PULL IT OUT THRU 25G CANNULA. FLEX TIP WAS NOT PRESENT ON FORCEPS ONCE OUTSIDE THE EYE. SURGEON PERFORMED ADDITIONAL EXAMINATIONS OF POSTERIOR CHAMBER OF EYE BUT WAS UNABLE TO VISUALIZE THE FLEX TIP AND ABORTED THE SEARCH. NO PATIENT INJURY WAS REPORTED.

N

Patient 1

THE DEVICE IN QUESTION WAS REQUESTED FOR OUR INVESTIGATION BUT WAS NOT RETURNED. ALL DEVICES FROM THIS LOT WERE DISTRIBUTED (LAST DATE OF DISTRIBUTION OF THIS LOT WAS 01/14/2015) WITH NO OTHER COMPLAINTS REPORTED FOR THIS LOT NUMBER NOR ANY SIMILAR COMPLAINTS EVER REPORTED FOR THIS PRODUCT NUMBER IN THE PAST TEN YEARS. THERE WAS NO PATIENT INJURY REPORTED.