FDA.reportPublic FDA data

MAUDE MDR 6843986

MDR report key
6843986
Report number
2027111-2017-01970
Event key
0
Event type
3
Date of event
2017-03-16
Date received
2017-09-05
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
1C8501, S ALEXIS LAP SYS 6/BXKGWAPPLIED MEDICAL RESOURCESKGWC85011013570011273550Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-050

Event Narratives#

N

Patient 1

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

D

Patient 1

PROCEDURE PERFORMED: LAP HEMI COLECTOMY EVENT DESCRIPTION: "THE SHEATH WAS TORN DURING THE SURGERY." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM SALES MANAGER ON TUESDAY (B)(6) 2017: THE SURGEON/STAFF REALIZE THE SHEATH WAS TORN DURING THE SURGERY, AFTER BEING INSERTED TO THE PATIENT BODY. THERE WAS NO DAMAGE ON THE CAP. COMMON LAPAROSCOPIC INSTRUMENTS WERE USED THROUGH THE TROCAR ON THE CAP. THE SHEATH PARTICULATED AND ALL MATERIAL WAS RETRIEVED. TYPE OF INTERVENTION: UNK. PATIENT STATUS: "NO PATIENT INJURY".