FDA.reportPublic FDA data

MAUDE MDR 7430689

MDR report key
7430689
Report number
3004444684-2018-00001
Event key
0
Event type
3
Date of event
2018-03-13
Date received
2018-04-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. RONEN COHEN
Address
7A INDUSTRIAL PARK POB 3030 OMER, ISRAEL 84965 IS
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSEENDSTAPLERMEDIGUS LTDODEMUSE ENDOSTAPLERMEMA1010005R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-04-1301. H

Event Narratives#

N

Patient 1

SINCE THE DEVICE WAS NOT RETURNED, NO CONCLUSION CAN BE MADE REGARDING WHETHER THE DEVICE CONTRIBUTED TO THE EVENT. HOWEVER, A REVIEW OF MANUFACTURING, DEVICE HISTORY, AND QUALITY CONTROL RECORDS FOUND THAT THE DEVICE MET ALL SPECIFICATIONS AND WAS IN COMPLIANCE.

D

Patient 1

THE PATIENT IS AN ACTIVE (B)(6) YEAR OLD WOMAN IN GENERAL GOOD HEALTH EXCEPT AS NOTED IN "OTHER RELEVANT HISTORY." THE PROCEDURE WAS UNEVENTFUL. ON THE DAY AFTER THE PROCEDURE, SHE COMPLAINED OF SHORTNESS OF BREATH AND RETROSTERNAL PAIN. THERE WERE NO CLINICAL SIGNS OF AN INFLAMMATORY RESPONSE BUT A CT SCAN DISCLOSED SMALL PNEUMOMEDIASTINUM AND PLEURAL EFFUSION. A CHEST DRAIN WAS PLACED AND A SMALL AMOUNT OF CLEAR FLUID WAS DRAINED. THE FLUID WAS A TRANSUDATE (PROTEIN