FDA.reportPublic FDA data

MAUDE MDR 7162466

MDR report key
7162466
Report number
2027111-2018-00001
Event key
0
Event type
3
Date of event
2017-12-18
Date received
2018-01-03
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
1C8313, XXS ALEXIS WND PROT/RET 5/BXKGWAPPLIED MEDICALKGWC83131013555011270927Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-01-030

Event Narratives#

N

Patient 1

THE EVENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

D

Patient 1

PROCEDURE PERFORMED: EXCISION BIOPSY CERVICAL NODE INCIDENT DESCRIPTION: FIRST TIME MEETING [PHYSICIAN] WHO IS AN ENT SURGEON. AGREED TO TRY AN ALEXIS FOR HIS EXCISION BIOPSY OF CERVICAL NODE. IN SERVICED ON HOW TO USE BEFORE THE PROCEDURE AND SHOWED HIM AND HIS REGISTRAR A VIDEO OF THE ALEXIS BEING USED IN A THYROIDECTOMY. AFTER MAKING HIS INCISION AND SKIN FLAP HE TRIED TO PLACE THE XS AKEXIS BUT IT WAS TOO LARGE. I OPENED A STERILE XXS WHICH FIT IN THE SKIN FLAP. WHEN ROLLING THE ALEXIS DOWN [PHYSICIAN] AND [HIS REGISTRAR] HELD THE OUTER RING EITHER SIDE AND ROLLED DOWNWARDS. THE SHEATH BECAME TWISTED AS THEY ROLLED DOWN SO THEY WERE UNABLE TO GET THE CIRCUMFRIENTAL RETRACTION. THEY TRIED TO CORRECT THE TWIST BUT IT DIDN'T WORK SO THEY REMOVED THE ALEXIS BY BULLING THE STRING THROUGH THE MIDDLE. WHEN THE ALEXIS WAS PASSED TO THE SCRUB NURSE I NOTICED IT HAD TORN WHERE THE SHEATH WAS TWISTED OVER THE OUTER RING. MENTIONED TO THE SURGEON ABOUT THE RIP AND HE WAS AWARE OF THE RIP AND THINKS HE MAY HAVE CAUSED IT WHEN ROLLING THE SHEATH DOWN . PATIENT STATUS: DID A PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT? NO. TYPE OF INTERVENTION: NI.