FDA.reportPublic FDA data

MAUDE MDR 9908338

MDR report key
9908338
Report number
2647580-2020-01156
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
1MULTIFIRE ENDO HERNIALAPAROSCOPE, GENERAL & PLASTIC SURGERYUS SURGICAL PUERTO RICOGCJ174027174027P9J0517YN R

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, WHEN THE DEVICE WAS USED TO CLOSE THE MESENTERIC DEFECT DURING A LAPAROSCOPIC GASTRIC BYPASS, THE STAPLE CAME OUT WITHOUT CORRECTLY FOLDING AND THE TWO STAPLES WERE FIRED AT THE SAME TIME CAUSING IT TO JAM. A RELOAD WAS ALSO FIRED AND THIS PROBLEM OCCLUDED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.