FDA.reportPublic FDA data

MAUDE MDR 6709305

MDR report key
6709305
Report number
2027111-2017-01900
Event key
0
Event type
3
Date of event
2017-06-13
Date received
2017-07-12
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
WENDY KOBAYASHI
Address
22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US
Phone
949-949-9497
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1C8502, M ALEXIS LAP SYS 6/BXKGWAPPLIED MEDICAL RESOURCESKGWC85021013571011285187Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-120

Event Narratives#

N

Patient 1

RA HAS RECEIVED THE EVENT DEVICE AND THE PRODUCT HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

D

Patient 1

PROCEDURE PERFORMED: LAP DONOR NEPHRECTOMY EVENT DESCRIPTION: PART OF CAP BROKE OFF AND FELL IN PATIENT. THEY USE THE CAP TO INTRODUCE CD004 WITHOUT TROCAR. ADDITION INFORMATION RECEIVED ON TUESDAY, JULY 4, 2017 THAT THE HOSPITAL DOES NOT KNOW FOR SURE AT WHAT POINT THE CAP BROKE OFF, THEY NOTICED IT BECAUSE THERE WAS A LEAKAGE AFTER TISSUE REMOVAL WITH INZII. THEY DID NOT USE ANY OTHER INSTRUMENTS. WITH RESPECT TO EXPERIENCE THE SURGEON USED THE PRODUCT AROUND THE 3RD OR 4TH TIME. ONLY THE CAP WILL BE REMOVED, THEY THREW AWAY THE PIECE THAT BROKE OFF, SO THEY ONLY SAVED THE CAP. COMMENT FROM THE HOSPITAL: ''WE REMOVED THE KIDNEY AS USUAL THROUGH THE PORT AND PLACED THE CAP BACK ON THE ALEXIS. WE NOTICED THAT THERE WAS A LEAKAGE, VERY UNPLEASANT. WHEN WE CHECKED THE CAP FOR THE LEAKAGE WE NOTICED THAT A PART OF THE CAP WAS BROKEN OFF. A PIECE OF THE SEAL.''. TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.