FDA.reportPublic FDA data

MAUDE MDR 9753736

MDR report key
9753736
Report number
2027111-2020-00378
Event key
0
Event type
3
Date received
2020-02-26
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
1C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BXLAPAROSCOPIC ACCESSORIES, GYNECOLOGICAPPLIED MEDICAL RESOURCESNWVC4130UNKUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-260

Event Narratives#

N

Patient 1

NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT # HAS BEEN PROVIDED TO MANUFACTURER. A FOLLOW-UP REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED.

D

Patient 1

PROCEDURE PERFORMED: UNKNOWN BARIATRIC SURGERY. REP. WASN'T PRESENT FOR THE CASE. STATED THAT AS THE GRASPER WAS BEING ROTATED 90 DEGREES, THE TIP OF ONE JAW BROKE OFF. IT HAS BEEN CONFIRMED THAT THE JAWS DIDN'T FULLY DETACH AND ONLY A PIECE OF THE JAW BROKE OFF. NOTHING FELL INTO THE PATIENT AS THE PIECE JUST REMAINED "DANGLED" FROM THE JAW. THE SURGEON WAS GRASPING OMENTUM TISSUE WHEN THE BREAKAGE OCCURRED. THERE WERE NO CONCOMITANT DEVICES AND IT IS CURRENTLY UNKNOWN AS TO HOW THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY AND THE PRODUCT IS NOT EXPECTED TO RETURN AS IT WAS DISCARDED IMMEDIATELY AFTER USE. THE REP. HAS MENTIONED THAT THIS HAS HAPPENED A TOTAL OF 3 TIMES. ADDITIONAL INFORMATION WAS RECEIVED FROM [NAME], APPLIED MEDICAL ACCOUNT MANAGER, VIA E-MAIL ON FEBRUARY 4TH, 2020: "THEY DIDN?T KNOW THE DATES OF THE SURGERIES. THEY HAD TO OPEN SECOND DEVICES TO COMPLETE THE CASES. THE RIGHT PEOPLE DID NOT KNOW IN TIME TO GET LOT # FOR THE GRASPERS. THESE WERE BARIATRIC CASES. THE RIGHT PEOPLE DID NOT KNOW ABOUT THE DEVICE COMPLAINTS UNTIL THEY WERE NOTIFIED WITH THE LAST CASE. FOR THAT MATTER THEY DID NOT HEAR ABOUT THE LAST CASE IN ORDER TO GET THE GRASPER NOT A LOT NUMBER. I WILL FORWARD THE E-MAIL STRING FROM THE PA WHOM I SPOKE WITH." INTERVENTION: OPENED A SECOND DEVICE TO COMPLETE THE CASE. PATIENT STATUS: NO PATIENT INJURY OCCURRED.