FDA.reportPublic FDA data

MAUDE MDR 6898274

MDR report key
6898274
Report number
3005075853-2017-05220
Event key
0
Event type
3
Date of event
2017-09-06
Date received
2017-09-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MILTON GARRETT
Address
475 CALLE C GUAYNABO 00969
Phone
513-513-5133
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LIGACLIP*ENDO MED/LG APPLIERLIGACLIPETHICON ENDO-SURGERY, LLC.HBTEL314NA* R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-270

Event Narratives#

N

Patient 1

(B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT IS THE CORRECT PROCEDURE DATE AND WHAT IS THE CORRECT EVENT DATE AS YOU HAVE THE PROCEDURE DATE AS (B)(6) 2017 AND THE EVENT DATE AS (B)(6) 2017? WAS THERE ONLY ONE PROCEDURE? OR WAS THERE A RE-OPERATION? IF THERE WAS A RE-OPERATION, WHAT WAS THE REASON FOR RE-OPERATION?

D

Patient 1

IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY, WHEN THEY CLIPPED THE CYSTIC DUCT THE TWO CLIPS WENT OUT OF PLACE. LUCKILY, THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. THERE CLIPS WERE RELEASED. THEY USED ANOTHER CHALANGER. THERE WAS NO NEED TO RE-OPERATE. THERE WAS NO SERIOUS DAMAGE. THERE WERE NO PATIENT CONSEQUENCES.