FDA.reportPublic FDA data

MAUDE MDR 9902302

MDR report key
9902302
Report number
2647580-2020-01136
Event key
0
Event type
3
Date of event
2020-03-10
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LISA HERNANDEZ
Address
60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US
Phone
203-203-2034
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PREMIUM SURGICLIP IIICLIP, IMPLANTABLEUS SURGICAL PUERTO RICOFZP133650133650P9G1363Y* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

ACCORDING TO THE REPORTER, DURING AN OPEN NEUROSURGERY, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE OF THE INSTRUMENTS YET THERE WERE ISSUES LOADING OR FIRING THE CLIPS. THE JAWS WERE NOT ABLE TO CLOSE. IT WAS UNKNOWN IF ANY CLIPS WERE ABLE TO LOAD INTO THE JAWS. THERE WAS NO PATIENT INJURY. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE.