FDA.reportPublic FDA data

MAUDE MDR 7049795

MDR report key
7049795
Report number
2027111-2017-02121
Event key
0
Event type
3
Date of event
2016-12-02
Date received
2017-11-21
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 RESOURCESKGWC85021013571011256507Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-210

Event Narratives#

N

Patient 1

THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. UPON VISUAL INSPECTION, ENGINEERING CONFIRMED THE COMPLAINANT'S EXPERIENCE OF A TEAR IN THE SHEATH. BASED ON THE CONDITION OF THE RETURNED UNIT, IT IS LIKELY THAT THE REPORTED EVENT WAS CAUSED BY INSTRUMENTS THAT WERE USED DURING THE PROCEDURE. ENGINEERING DETERMINED THAT THE DAMAGE TO THE SHEATH WAS CAUSED BY OUTWARD STRETCHING OF THE FILM FROM THE PUNCTURE HOLE. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS, AS NECESSARY, TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS. THIS REPORT REPRESENTS THE INITIAL AND FINAL REPORT.

D

Patient 1

PROCEDURE PERFORMED -LAP HEMI COLECTOMY. "THIS ALEXIS WAS NOTICED THAT IT WAS TORN, WHEN THE SCRUB NURSE UNPACK AND CHECK THE PRODUCT BEFORE USE, DURING THE SURGERY." PATIENT STATUS- NO PATIENT INJURY OR ILLNESS OCCURRED THAT WAS ASSOCIATED WITH THE COMPLAINT EVENT.