FDA.reportPublic FDA data

MAUDE MDR 7343906

MDR report key
7343906
Report number
2027111-2018-00087
Event key
0
Event type
3
Date of event
2018-02-14
Date received
2018-03-15
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#

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
1C8313, XXS ALEXIS WND PROT/RET 5/BXKGWAPPLIED MEDICAL RESOURCESKGWC8313101355501UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-03-150

Event Narratives#

N

Patient 1

INVESTIGATION SUMMARY: THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE EVENT. 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.

D

Patient 1

PROCEDURE PERFORMED: REVISION OF GASTRIC SLEEVE. EVENT DESCRIPTION: "DR (SURGEON) INSERTED THE XXS ALEXIS AS PART OF A TRIAL OF THE NOVEL APPROACH IN CLINICAL TRIAL FOR SPECIMEN REMOVAL OF THE GASTRIC SLEEVE APPROACH. DR DID NOT TAKE OFF THE HOUSING OF THE CANNULA INITIALLY AND ALEXIS WAS DIFFICULT TO INSERT FULLY AND SO DR PULLED OUT THE DEVICE WITH A TOOTHED GRASPER FROM THE HOUSING BEFORE REINSERTING BACK INTO CANNULA WITHOUT THE HOUSING. DR INSERTED HIS FINGERS THROUGHOUT THE REMOVAL OF SPECIMEN DUE TO LARGER PORTION OF STOMACH AND TOOTHED GRASPERS TO FACILITATE REMOVAL. ALEXIS WAS VISIBLE TORN WHEN SURGEON REMOVED IT FROM THE ABDOMEN." TYPE OF INTERVENTION: UNK. PATIENT STATUS: UNK.