FDA.reportPublic FDA data

MAUDE MDR 5989418

MDR report key
5989418
Report number
2027111-2016-00624
Event key
0
Event type
3
Date of event
2016-09-02
Date received
2016-09-30
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
1CNO11, GELPOINT PATH 5.5CMFERAPPLIED MEDICAL RESOURCESFERCNO111014243011268347R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-09-300

Event Narratives#

N

Patient 1

NO PRODUCT IS BEING RETURNED FOR EVALUATION BUT LOT # IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FOLLOW-UP REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA. THERE IS NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

D

Patient 1

"THE INNER BLACK SEAL OUT OF THE TROCAR CAME AWAY AND WAS FOUND INSIDE THE CANNULA WHILST IN THE PATIENT. THE TROCAR WAS EQUALLY SPACED FROM ONE ANOTHER AND NOT TOO CLOSE TO THE OUTER RING. THE ENTIRE SEAL POPPED OUT. THE REASON WAS BECAUSE THE SURGEON USED A 'SWAP ON A STICK', TO CLEAN AND WIPE THE SEAL OF BLOOD SO THE CAMERA WOULDN'T GET DIRTY ON REINTRODUCTION, AND INADVERTENTLY PUSHED TOO DEEP AND PUSHED THE BLACK SEAL OUT." INTERVENTION - "IT WAS RETRIEVED SAFELY." PATIENT STATUS - "FINE."

N

Patient 1

THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. BASED ON THE DESCRIPTION OF THE COMPLAINANT'S EXPERIENCE, THE SEAL DISLODGEMENT WAS CAUSED BY THE SURGEON WHEN A SWAB ON A STICK WAS USED TO CLEAN THE INTERNAL SEAL. THE SWAB WAS INADVERTENTLY PUSHED TOO DEEP INTO THE TROCAR AND PUSHED THE SEAL OUT. THIS COULD OCCUR IF THE SWAB WAS INSERTED AT AN ANGLE INSTEAD OF AXIALLY. THE INSTRUCTIONS FOR USE (IFU) STATES THAT "ALL INSTRUMENTS SHOULD BE CENTERED AXIALLY WHEN INSERTED THROUGH THE SEAL." 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.